Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2026-02-11 @ 5:49 PM
Study NCT ID:
NCT03299959
Status:
COMPLETED
Last Update Posted:
2025-12-05
First Post:
2017-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Agili-C™ Implant Performance Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France', 'Slovenia'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'datasharing.gcs@smith-nephew.com', 'phone': '07811407089', 'title': 'Senior Manager Clinical Compliance', 'organization': 'Smith+Nephew, Inc'}, 'certainAgreement': {'otherDetails': 'The only disclosure restriction on the PI is the sponsor can review results communications before public release and can prohibit communications about trial results for less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor may request amendments or object to the publication. If requested, the PI will use best efforts to accept the incorporation into the publication any such amendments.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from surgery through the end of study, approximately 60 months', 'eventGroups': [{'id': 'EG000', 'title': 'Agili-C™', 'description': 'Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach', 'otherNumAtRisk': 167, 'deathsNumAtRisk': 167, 'otherNumAffected': 120, 'seriousNumAtRisk': 167, 'deathsNumAffected': 1, 'seriousNumAffected': 49}, {'id': 'EG001', 'title': 'Surgical Standard of Care (SSOC)', 'description': 'Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).', 'otherNumAtRisk': 84, 'deathsNumAtRisk': 84, 'otherNumAffected': 68, 'seriousNumAtRisk': 84, 'deathsNumAffected': 0, 'seriousNumAffected': 25}], 'otherEvents': [{'term': 'atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'arteriovenous malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'middle ear effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'secondary hypogonadism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'blepharospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'eyelid ptosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'retinal vein occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'anal fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'anal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': "crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'adverse drug reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'coxsackie viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ear infection fungal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'molluscum contagiosum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'oesophageal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'onychomycosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'orchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'pharyngitis streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'stitch abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'suspected covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'animal bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'cartilage injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'chemical burns of eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'epicondylitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'facial bones fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'iatrogenic injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'iliotibial band syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'inadequate osteointegration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'joint injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'muscle rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'neck injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'post-traumatic neck syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'repetitive strain injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'sciatic nerve injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'tooth fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'abnormal weight gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'obesity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'chondropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'foot deformity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 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1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'lymphoedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 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'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Joint locking', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle atrophy compared to baseline', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Progression of osteoarthritis compared to baseline', 'notes': 'Progression of osteoarthritis (degeneration of surrounding bone and cartilage or delamination) compared to baseline', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vascular damage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound complications (wound dehiscence, hematoma, site drainage or superficial infection)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 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'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'allergy to metals', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'covid-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'cartilage injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'meniscus injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'nerve injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'post procedural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'traumatic arthropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ankylosing spondylitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'cervical spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'intervertebral disc degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'osteochondrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'patellofemoral pain syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'spinal synovial cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'choroid neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'foetal hypokinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'device breakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'menometrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ligament operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased range of motion compared to baseline', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Deep Vein Thrombosis (DVT) and related complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased transient or chronic pain in the operated joint, compared to baseline', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection & related symptoms', 'notes': 'Infection (including septicemia or deep infections in the operated joint) and related symptoms, such as fever and/or pus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Progression of osteoarthritis compared to baseline', 'notes': 'Progression of osteoarthritis (degeneration of surrounding bone and cartilage or delamination) compared to baseline', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score Change From Baseline to 60 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Agili-C™', 'description': 'Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach'}, {'id': 'OG001', 'title': 'Surgical Standard of Care (SSOC)', 'description': 'Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).'}], 'classes': [{'categories': [{'measurements': [{'value': '37.71', 'groupId': 'OG000', 'lowerLimit': '34.47', 'upperLimit': '40.93'}, {'value': '18.68', 'groupId': 'OG001', 'lowerLimit': '13.89', 'upperLimit': '23.43'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 60 Months', 'description': 'Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score consists of 9 items. A Likert scale is used with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Scores are transformed to a 0 to 100 scale, with 0 representing a worse outcome and 100 representing a better outcome.\n\nThe change from baseline score is reported as the mean of posterior distribution with 95% credible interval using the Bayesian model.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline for the specified time frame.'}, {'type': 'SECONDARY', 'title': 'Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QOL) Score Change From Baseline to 60 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Agili-C™', 'description': 'Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach'}, {'id': 'OG001', 'title': 'Surgical Standard of Care (SSOC)', 'description': 'Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).'}], 'classes': [{'categories': [{'measurements': [{'value': '45.22', 'groupId': 'OG000', 'lowerLimit': '40.49', 'upperLimit': '49.93'}, {'value': '22.29', 'groupId': 'OG001', 'lowerLimit': '15.53', 'upperLimit': '29.15'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 60 Months', 'description': 'Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QOL) Score consists of 4 items. A Likert scale is used with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Scores are transformed to a 0 to 100 scale, with 0 representing a worse outcome and 100 representing a better outcome.\n\nThe change from baseline score is reported as the mean of posterior distribution with 95% credible interval using the Bayesian model.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline for the specified time frame.'}, {'type': 'SECONDARY', 'title': 'Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Daily Living (ADL) Score Change From Baseline to 60 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Agili-C™', 'description': 'Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach'}, {'id': 'OG001', 'title': 'Surgical Standard of Care (SSOC)', 'description': 'Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).'}], 'classes': [{'categories': [{'measurements': [{'value': '33.03', 'groupId': 'OG000', 'lowerLimit': '29.84', 'upperLimit': '36.18'}, {'value': '16.45', 'groupId': 'OG001', 'lowerLimit': '11.84', 'upperLimit': '21.12'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 60 Months', 'description': 'Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Daily Living (ADL) Score consists of 17 items. A Likert scale is used with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Scores are transformed to a 0 to 100 scale, with 0 representing a worse outcome and 100 representing a better outcome.\n\nThe change from baseline score is reported as the mean of posterior distribution with 95% credible interval using the Bayesian model.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline for the specified time frame.'}, {'type': 'SECONDARY', 'title': 'Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptoms Score Change From Baseline to 60 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Agili-C™', 'description': 'Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach'}, {'id': 'OG001', 'title': 'Surgical Standard of Care (SSOC)', 'description': 'Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).'}], 'classes': [{'categories': [{'measurements': [{'value': '30.52', 'groupId': 'OG000', 'lowerLimit': '27.00', 'upperLimit': '34.02'}, {'value': '15.52', 'groupId': 'OG001', 'lowerLimit': '10.38', 'upperLimit': '20.72'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 60 Months', 'description': 'Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptoms Score consists of 7 items. A Likert scale is used with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Scores are transformed to a 0 to 100 scale, with 0 representing a worse outcome and 100 representing a better outcome.\n\nThe change from baseline score is reported as the mean of posterior distribution with 95% credible interval using the Bayesian model.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline for the specified time frame.'}, {'type': 'SECONDARY', 'title': 'Knee Injury and Osteoarthritis Outcome Score (KOOS) Sports Score Change From Baseline to 60 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Agili-C™', 'description': 'Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach'}, {'id': 'OG001', 'title': 'Surgical Standard of Care (SSOC)', 'description': 'Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).'}], 'classes': [{'categories': [{'measurements': [{'value': '47.32', 'groupId': 'OG000', 'lowerLimit': '42.46', 'upperLimit': '52.18'}, {'value': '25.11', 'groupId': 'OG001', 'lowerLimit': '18.15', 'upperLimit': '32.08'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 60 Months', 'description': 'Knee Injury and Osteoarthritis Outcome Score (KOOS) Sports Score consists of 5 items. A Likert scale is used with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Scores are transformed to a 0 to 100 scale, with 0 representing a worse outcome and 100 representing a better outcome.\n\nThe change from baseline score is reported as the mean of posterior distribution with 95% credible interval using the Bayesian model.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline for the specified time frame.'}, {'type': 'SECONDARY', 'title': 'Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score Responder Rate Change From Baseline to 60 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Agili-C™', 'description': 'Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach'}, {'id': 'OG001', 'title': 'Surgical Standard of Care (SSOC)', 'description': 'Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.74', 'groupId': 'OG000', 'lowerLimit': '0.67', 'upperLimit': '0.81'}, {'value': '0.34', 'groupId': 'OG001', 'lowerLimit': '0.24', 'upperLimit': '0.46'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 60 Months', 'description': 'Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score consists of 5 subscales. A Likert scale is used with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Subscale scores are combined to produce the Overall Score that is transformed to a 0 to 100 scale, with 0 representing a worse outcome and 100 representing a better outcome. Responder rate was defined as the proportion of participants achieving ≥30-point improvement from baseline to 60 months in the KOOS Overall Score.\n\nThe change from baseline data is reported as the mean of posterior distribution with 95% credible interval using the Bayesian model.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline for the specified time frame.'}, {'type': 'SECONDARY', 'title': 'Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months and 48 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Agili-C™', 'description': 'Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach'}, {'id': 'OG001', 'title': 'Surgical Standard of Care (SSOC)', 'description': 'Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).'}], 'classes': [{'title': 'Change from Baseline to 36 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.4', 'spread': '21.3', 'groupId': 'OG000', 'lowerLimit': '-6.8', 'upperLimit': '86.4'}, {'value': '19.3', 'spread': '19.2', 'groupId': 'OG001', 'lowerLimit': '-7.8', 'upperLimit': '55.7'}]}]}, {'title': 'Change from Baseline to 48 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.9', 'spread': '21.6', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '86.4'}, {'value': '17.3', 'spread': '20.0', 'groupId': 'OG001', 'lowerLimit': '-29.6', 'upperLimit': '59.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 36 Months, and 48 Months', 'description': 'Change from Baseline to 36 Months and 48 months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline. Number analyzed in each row indicates participants with data collected for the time frame indicated.'}, {'type': 'SECONDARY', 'title': 'International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score Change From Baseline to 36 Months, 48 Months, and 60 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Agili-C™', 'description': 'Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach'}, {'id': 'OG001', 'title': 'Surgical Standard of Care (SSOC)', 'description': 'Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).'}], 'classes': [{'title': 'Change from Baseline to 36 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.1', 'spread': '22.6', 'groupId': 'OG000', 'lowerLimit': '-20.7', 'upperLimit': '82.8'}, {'value': '18.8', 'spread': '20.6', 'groupId': 'OG001', 'lowerLimit': '-11.5', 'upperLimit': '71.3'}]}]}, {'title': 'Change from Baseline to 48 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.6', 'spread': '23.0', 'groupId': 'OG000', 'lowerLimit': '-13.8', 'upperLimit': '82.8'}, {'value': '17.9', 'spread': '21.3', 'groupId': 'OG001', 'lowerLimit': '-16.1', 'upperLimit': '69.0'}]}]}, {'title': 'Change from Baseline to 60 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.0', 'spread': '24.2', 'groupId': 'OG000', 'lowerLimit': '-8.1', 'upperLimit': '82.8'}, {'value': '18.4', 'spread': '21.9', 'groupId': 'OG001', 'lowerLimit': '-13.8', 'upperLimit': '70.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 36 Months, 48 Months, and 60 Months', 'description': 'Change from Baseline to 36 Months, 48 Months, and 60 Months in the International Knee Documentation Committee (IKDC) Subjective Evaluation score. The IKDC Score was developed to detect improvement or deterioration in symptoms, function, and sports activities due to knee impairment, including patients with meniscal injuries. The possible score ranges from 0 to 100, with a higher score indicating no limitation with daily or sporting activities and the absence of symptoms (i.e., a better outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline. Number analyzed in each row indicates participants with data collected for the time frame indicated.'}, {'type': 'SECONDARY', 'title': 'Tegner Activity Scale Change From Baseline to 36 Months, 48 Months, and 60 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Agili-C™', 'description': 'Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach'}, {'id': 'OG001', 'title': 'Surgical Standard of Care (SSOC)', 'description': 'Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).'}], 'classes': [{'title': 'Change from Baseline to 36 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '1.9', 'groupId': 'OG000', 'lowerLimit': '-3', 'upperLimit': '9'}, {'value': '1.0', 'spread': '1.5', 'groupId': 'OG001', 'lowerLimit': '-1', 'upperLimit': '8'}]}]}, {'title': 'Change from Baseline to 48 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.8', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '8'}, {'value': '0.9', 'spread': '1.6', 'groupId': 'OG001', 'lowerLimit': '-2', 'upperLimit': '8'}]}]}, {'title': 'Change from Baseline to 60 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '1.8', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '7'}, {'value': '0.9', 'spread': '1.7', 'groupId': 'OG001', 'lowerLimit': '-2', 'upperLimit': '8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 36 Months, 48 Months, and 60 Months', 'description': 'Change from Baseline to 36 Months, 48 Months, and 60 Months in Tegner activity scale. The Tegner activity scale was designed as a score of activity level to complement other functional scores for patients with ligamentous injuries. The Tegner activity scale is a numerical scale ranging from 0 to 10, with a higher score indicating higher levels of activity (i.e., a better outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline. Number analyzed in each row indicates participants with data collected for the time frame indicated.'}, {'type': 'SECONDARY', 'title': 'Short Form Survey (SF-12) Physical Component Score Change From Baseline to 36 Months, 48 Months, and 60 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Agili-C™', 'description': 'Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach'}, {'id': 'OG001', 'title': 'Surgical Standard of Care (SSOC)', 'description': 'Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).'}], 'classes': [{'title': 'Change from Baseline to 36 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.4', 'spread': '9.8', 'groupId': 'OG000', 'lowerLimit': '-4.0', 'upperLimit': '39.4'}, {'value': '7.3', 'spread': '10.9', 'groupId': 'OG001', 'lowerLimit': '-18.4', 'upperLimit': '40.3'}]}]}, {'title': 'Change from Baseline to 48 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.5', 'spread': '10.6', 'groupId': 'OG000', 'lowerLimit': '-14.2', 'upperLimit': '36.2'}, {'value': '6.4', 'spread': '10.9', 'groupId': 'OG001', 'lowerLimit': '-14.8', 'upperLimit': '38.7'}]}]}, {'title': 'Change from Baseline to 60 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.2', 'spread': '11.5', 'groupId': 'OG000', 'lowerLimit': '-20.9', 'upperLimit': '39.0'}, {'value': '6.1', 'spread': '11.0', 'groupId': 'OG001', 'lowerLimit': '-16.3', 'upperLimit': '42.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 36 Months, 48 Months, and 60 Months', 'description': 'Change from Baseline to 36 Months, 48 Months, and 60 Months in SF-12 Physical Component Score. The SF-12 Physical Component Score assesses health related quality of life. The score is on a scale ranging from 0 to 100, with a higher score indicating a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline. Number analyzed in each row indicates participants with data collected for the time frame indicated.'}, {'type': 'SECONDARY', 'title': 'Short Form Survey (SF-12) Mental Component Score Change From Baseline to 36 Months, 48 Months, and 60 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Agili-C™', 'description': 'Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach'}, {'id': 'OG001', 'title': 'Surgical Standard of Care (SSOC)', 'description': 'Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).'}], 'classes': [{'title': 'Change from Baseline to 36 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.4', 'spread': '12.8', 'groupId': 'OG000', 'lowerLimit': '-23.2', 'upperLimit': '36.4'}, {'value': '1.7', 'spread': '8.7', 'groupId': 'OG001', 'lowerLimit': '-16.6', 'upperLimit': '37.3'}]}]}, {'title': 'Change from Baseline to 48 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.2', 'spread': '12.9', 'groupId': 'OG000', 'lowerLimit': '-23.5', 'upperLimit': '38.1'}, {'value': '1.7', 'spread': '10.1', 'groupId': 'OG001', 'lowerLimit': '-19.4', 'upperLimit': '34.5'}]}]}, {'title': 'Change from Baseline to 60 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.3', 'spread': '13.7', 'groupId': 'OG000', 'lowerLimit': '-27.7', 'upperLimit': '36.4'}, {'value': '1.4', 'spread': '9.4', 'groupId': 'OG001', 'lowerLimit': '-16.9', 'upperLimit': '37.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 36 Months, 48 Months, and 60 Months', 'description': 'Change from Baseline to 36 Months, 48 Months, and 60 Months in SF-12 Mental Component Score. The SF-12 Mental Component Score assesses mental health and well-being. The score is on a scale ranging from 0 to 100, with a higher score indicating a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline. Number analyzed in each row indicates participants with data collected for the time frame indicated.'}, {'type': 'SECONDARY', 'title': 'Chondral Lesions: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Agili-C™', 'description': 'Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach'}, {'id': 'OG001', 'title': 'Surgical Standard of Care (SSOC)', 'description': 'Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).'}], 'classes': [{'title': 'Change from Baseline to 36 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.9', 'spread': '21.3', 'groupId': 'OG000', 'lowerLimit': '-6.8', 'upperLimit': '86.4'}, {'value': '19.8', 'spread': '19.4', 'groupId': 'OG001', 'lowerLimit': '-7.8', 'upperLimit': '55.7'}]}]}, {'title': 'Change from Baseline to 48 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.1', 'spread': '23.1', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '86.4'}, {'value': '19.0', 'spread': '19.3', 'groupId': 'OG001', 'lowerLimit': '-1.5', 'upperLimit': '59.5'}]}]}, {'title': 'Change from Baseline to 60 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.3', 'spread': '23.7', 'groupId': 'OG000', 'lowerLimit': '-2.5', 'upperLimit': '86.4'}, {'value': '18.5', 'spread': '20.1', 'groupId': 'OG001', 'lowerLimit': '-0.6', 'upperLimit': '64.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 36 Months, 48 Months, and 60 Months', 'description': 'Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants with Chondral Lesions measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline. Number analyzed in each row indicates only participants that had chondral lesions with data collected for the time frame indicated.'}, {'type': 'SECONDARY', 'title': 'Osteochondral Lesions: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Agili-C™', 'description': 'Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach'}, {'id': 'OG001', 'title': 'Surgical Standard of Care (SSOC)', 'description': 'Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).'}], 'classes': [{'title': 'Change from Baseline to 36 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39.0', 'spread': '21.1', 'groupId': 'OG000', 'lowerLimit': '-5.0', 'upperLimit': '79.0'}, {'value': '17.0', 'spread': '18.8', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '54.9'}]}]}, {'title': 'Change from Baseline to 48 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.5', 'spread': '19.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '80.3'}, {'value': '9.7', 'spread': '21.7', 'groupId': 'OG001', 'lowerLimit': '-29.6', 'upperLimit': '55.4'}]}]}, {'title': 'Change from Baseline to 60 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.6', 'spread': '22.9', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '80.5'}, {'value': '10.0', 'spread': '21.3', 'groupId': 'OG001', 'lowerLimit': '-26.9', 'upperLimit': '54.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 36 Months, 48 Months, and 60 Months', 'description': 'Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants with Osteochondral Lesions measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline. Number analyzed in each row indicates only participants that had osteochondral lesions with data collected for the time frame indicated.'}, {'type': 'SECONDARY', 'title': 'Single Lesion: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Agili-C™', 'description': 'Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach'}, {'id': 'OG001', 'title': 'Surgical Standard of Care (SSOC)', 'description': 'Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).'}], 'classes': [{'title': 'Change from Baseline to 36 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.7', 'spread': '19.6', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '86.4'}, {'value': '20.4', 'spread': '19.5', 'groupId': 'OG001', 'lowerLimit': '-1.0', 'upperLimit': '55.7'}]}]}, {'title': 'Change from Baseline to 48 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.8', 'spread': '20.8', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '86.4'}, {'value': '18.5', 'spread': '19.1', 'groupId': 'OG001', 'lowerLimit': '-1.5', 'upperLimit': '56.1'}]}]}, {'title': 'Change from Baseline to 60 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.5', 'spread': '22.5', 'groupId': 'OG000', 'lowerLimit': '-2.5', 'upperLimit': '86.4'}, {'value': '17.8', 'spread': '19.5', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '56.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 36 Months, 48 Months, and 60 Months', 'description': 'Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants with a Single Lesion measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline. Number analyzed in each row indicates only participants that had a single lesion with data collected for the time frame indicated.'}, {'type': 'SECONDARY', 'title': 'Multiple Lesions: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Agili-C™', 'description': 'Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach'}, {'id': 'OG001', 'title': 'Surgical Standard of Care (SSOC)', 'description': 'Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).'}], 'classes': [{'title': 'Change from Baseline to 36 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37.3', 'spread': '23.6', 'groupId': 'OG000', 'lowerLimit': '-6.8', 'upperLimit': '76.8'}, {'value': '16.6', 'spread': '18.7', 'groupId': 'OG001', 'lowerLimit': '-7.8', 'upperLimit': '53.7'}]}]}, {'title': 'Change from Baseline to 48 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.4', 'spread': '22.8', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '78.0'}, {'value': '14.7', 'spread': '21.9', 'groupId': 'OG001', 'lowerLimit': '-29.6', 'upperLimit': '59.5'}]}]}, {'title': 'Change from Baseline to 60 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.0', 'spread': '24.9', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '80.4'}, {'value': '14.9', 'spread': '22.6', 'groupId': 'OG001', 'lowerLimit': '-26.9', 'upperLimit': '64.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 36 Months, 48 Months, and 60 Months', 'description': 'Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants with Multiple Lesions measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline. Number analyzed in each row indicates only participants that had multiple lesions with data collected for the time frame indicated.'}, {'type': 'SECONDARY', 'title': 'Level of Osteoarthritis (Kellgren-Lawrence Grade 0-1): Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Agili-C™', 'description': 'Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach'}, {'id': 'OG001', 'title': 'Surgical Standard of Care (SSOC)', 'description': 'Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).'}], 'classes': [{'title': 'Change from Baseline to 36 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.5', 'spread': '20.6', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '86.4'}, {'value': '20.4', 'spread': '16.4', 'groupId': 'OG001', 'lowerLimit': '-1.0', 'upperLimit': '53.5'}]}]}, {'title': 'Change from Baseline to 48 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.1', 'spread': '21.7', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '86.4'}, {'value': '17.2', 'spread': '15.7', 'groupId': 'OG001', 'lowerLimit': '-1.5', 'upperLimit': '43.2'}]}]}, {'title': 'Change from Baseline to 60 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39.4', 'spread': '23.9', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '86.4'}, {'value': '14.3', 'spread': '15.3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '48.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 36 Months, 48 Months, and 60 Months', 'description': 'Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants based on their level of osteoarthritis measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).\n\nParticipants were categorized as without osteoarthritis based on Kellgren-Lawrence (K/L) grade of 0 to 1. K/L grading included Grade 0 (No evidence of osteoarthritis), Grade 1 (Doubtful), Grade 2 (Minimal), and Grade 3 (Moderate).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline. Number analyzed in each row indicates only participants with the specified level of osteoarthritis with data collected for the time frame indicated.'}, {'type': 'SECONDARY', 'title': 'Level of Osteoarthritis (Kellgren-Lawrence Grade 2-3): Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Agili-C™', 'description': 'Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach'}, {'id': 'OG001', 'title': 'Surgical Standard of Care (SSOC)', 'description': 'Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).'}], 'classes': [{'title': 'Change from Baseline to 36 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40.1', 'spread': '22.2', 'groupId': 'OG000', 'lowerLimit': '-6.8', 'upperLimit': '79.5'}, {'value': '18.7', 'spread': '20.7', 'groupId': 'OG001', 'lowerLimit': '-7.8', 'upperLimit': '55.7'}]}]}, {'title': 'Change from Baseline to 48 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40.5', 'spread': '21.5', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '79.5'}, {'value': '17.3', 'spread': '22.0', 'groupId': 'OG001', 'lowerLimit': '-29.6', 'upperLimit': '59.5'}]}]}, {'title': 'Change from Baseline to 60 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39.8', 'spread': '23.0', 'groupId': 'OG000', 'lowerLimit': '-2.5', 'upperLimit': '80.4'}, {'value': '18.2', 'spread': '22.6', 'groupId': 'OG001', 'lowerLimit': '-26.9', 'upperLimit': '64.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 36 Months, 48 Months, and 60 Months', 'description': 'Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants based on their level of osteoarthritis measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).\n\nParticipants categorized with osteoarthritis based on Kellgren-Lawrence (K/L) grade of 2 to 3. K/L grading included Grade 0 (No evidence of osteoarthritis), Grade 1 (Doubtful), Grade 2 (Minimal), or Grade 3 (Moderate).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline. Number analyzed in each row indicates only participants with the specified level of osteoarthritis with data collected for the time frame indicated.'}, {'type': 'SECONDARY', 'title': 'Total Lesion Area ≤3cm²: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Agili-C™', 'description': 'Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach'}, {'id': 'OG001', 'title': 'Surgical Standard of Care (SSOC)', 'description': 'Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).'}], 'classes': [{'title': 'Change from Baseline to 36 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.3', 'spread': '20.3', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '86.4'}, {'value': '21.5', 'spread': '17.8', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '55.7'}]}]}, {'title': 'Change from Baseline to 48 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.4', 'spread': '21.1', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '86.4'}, {'value': '20.7', 'spread': '19.3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '56.1'}]}]}, {'title': 'Change from Baseline to 60 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.2', 'spread': '22.1', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '86.4'}, {'value': '18.9', 'spread': '19.6', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '56.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 36 Months, 48 Months, and 60 Months', 'description': 'Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants with a lesion area ≤3cm² measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline. Number analyzed in each row indicates only participants with the specified lesion area size with data collected for the time frame indicated.'}, {'type': 'SECONDARY', 'title': 'Total Lesion Area >3cm²: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Agili-C™', 'description': 'Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach'}, {'id': 'OG001', 'title': 'Surgical Standard of Care (SSOC)', 'description': 'Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).'}], 'classes': [{'title': 'Change from Baseline to 36 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.5', 'spread': '21.8', 'groupId': 'OG000', 'lowerLimit': '-6.8', 'upperLimit': '79.5'}, {'value': '17.1', 'spread': '20.5', 'groupId': 'OG001', 'lowerLimit': '-7.8', 'upperLimit': '54.9'}]}]}, {'title': 'Change from Baseline to 48 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.3', 'spread': '21.7', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '79.8'}, {'value': '14.0', 'spread': '20.3', 'groupId': 'OG001', 'lowerLimit': '-29.6', 'upperLimit': '59.5'}]}]}, {'title': 'Change from Baseline to 60 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.8', 'spread': '24.2', 'groupId': 'OG000', 'lowerLimit': '-2.5', 'upperLimit': '81.7'}, {'value': '15.0', 'spread': '21.3', 'groupId': 'OG001', 'lowerLimit': '-26.9', 'upperLimit': '64.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 36 Months, 48 Months, and 60 Months', 'description': 'Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants with a lesion area \\>3cm² measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline. Number analyzed in each row indicates only participants with the specified lesion area size with data collected for the time frame indicated.'}, {'type': 'SECONDARY', 'title': 'Without Previous Ligament Reconstruction: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Agili-C™', 'description': 'Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach'}, {'id': 'OG001', 'title': 'Surgical Standard of Care (SSOC)', 'description': 'Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).'}], 'classes': [{'title': 'Change from Baseline to 36 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37.0', 'spread': '24.3', 'groupId': 'OG000', 'lowerLimit': '-6.8', 'upperLimit': '79.0'}, {'value': '18.1', 'spread': '19.7', 'groupId': 'OG001', 'lowerLimit': '-7.8', 'upperLimit': '54.9'}]}]}, {'title': 'Change from Baseline to 48 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.8', 'spread': '24.7', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '80.3'}, {'value': '12.3', 'spread': '19.1', 'groupId': 'OG001', 'lowerLimit': '-29.6', 'upperLimit': '59.5'}]}]}, {'title': 'Change from Baseline to 60 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.5', 'spread': '26.4', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '81.7'}, {'value': '11.8', 'spread': '19.9', 'groupId': 'OG001', 'lowerLimit': '-26.9', 'upperLimit': '64.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 36 Months, 48 Months, and 60 Months', 'description': 'Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants without previous ligament reconstruction was measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline. Number analyzed in each row indicates only participants without previous ligament reconstruction with data collected for the time frame indicated.'}, {'type': 'SECONDARY', 'title': 'With Previous Ligament Reconstruction: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Agili-C™', 'description': 'Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach'}, {'id': 'OG001', 'title': 'Surgical Standard of Care (SSOC)', 'description': 'Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).'}], 'classes': [{'title': 'Change from Baseline to 36 Months', 'categories': [{'measurements': [{'value': '34.7', 'spread': '19.9', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '58.3'}, {'value': '25.8', 'spread': '23.1', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '53.5'}]}]}, {'title': 'Change from Baseline to 48 Months', 'categories': [{'measurements': [{'value': '31.9', 'spread': '21.5', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '56.1'}, {'value': '23.4', 'spread': '23.3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '53.5'}]}]}, {'title': 'Change from Baseline to 60 Months', 'categories': [{'measurements': [{'value': '31.9', 'spread': '21.9', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '53.9'}, {'value': '25.7', 'spread': '24.6', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '53.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 36 Months, 48 Months, and 60 Months', 'description': 'Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants with previous ligament reconstruction was measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline. Number analyzed in each row indicates only participants with previous ligament reconstruction with data collected for the time frame indicated.'}, {'type': 'SECONDARY', 'title': 'With Intact Meniscus: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Agili-C™', 'description': 'Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach'}, {'id': 'OG001', 'title': 'Surgical Standard of Care (SSOC)', 'description': 'Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).'}], 'classes': [{'title': 'Change from Baseline to 36 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.9', 'spread': '19.5', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '79.0'}, {'value': '20.9', 'spread': '18.1', 'groupId': 'OG001', 'lowerLimit': '-1.0', 'upperLimit': '55.7'}]}]}, {'title': 'Change from Baseline to 48 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.0', 'spread': '20.1', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '80.3'}, {'value': '19.0', 'spread': '19.4', 'groupId': 'OG001', 'lowerLimit': '-1.5', 'upperLimit': '56.1'}]}]}, {'title': 'Change from Baseline to 60 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40.7', 'spread': '21.4', 'groupId': 'OG000', 'lowerLimit': '-2.5', 'upperLimit': '80.5'}, {'value': '18.3', 'spread': '19.1', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '56.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 36 Months, 48 Months, and 60 Months', 'description': 'Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants categorized by a meniscus status of intact meniscus (i.e., without a concomitant meniscectomy) was measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline. Number analyzed in each row indicates only participants in the meniscus status specified with data collected for the time frame indicated.'}, {'type': 'SECONDARY', 'title': 'With Previous Partial Meniscectomy: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Agili-C™', 'description': 'Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach'}, {'id': 'OG001', 'title': 'Surgical Standard of Care (SSOC)', 'description': 'Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).'}], 'classes': [{'title': 'Change from Baseline to 36 Months', 'categories': [{'measurements': [{'value': '38.4', 'spread': '26.2', 'groupId': 'OG000', 'lowerLimit': '-6.8', 'upperLimit': '75.8'}, {'value': '14.5', 'spread': '19.9', 'groupId': 'OG001', 'lowerLimit': '-7.8', 'upperLimit': '53.7'}]}]}, {'title': 'Change from Baseline to 48 Months', 'categories': [{'measurements': [{'value': '38.5', 'spread': '25.5', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '79.8'}, {'value': '11.3', 'spread': '20.1', 'groupId': 'OG001', 'lowerLimit': '-29.6', 'upperLimit': '59.5'}]}]}, {'title': 'Change from Baseline to 60 Months', 'categories': [{'measurements': [{'value': '38.3', 'spread': '26.2', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '81.7'}, {'value': '11.7', 'spread': '21.9', 'groupId': 'OG001', 'lowerLimit': '-26.9', 'upperLimit': '64.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 36 Months, 48 Months, and 60 Months', 'description': 'Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants categorized by a meniscus status of previous partial meniscectomy (i.e., with a prior meniscectomy) was measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline. Number analyzed in each row indicates only participants in the meniscus status specified with data collected for the time frame indicated.'}, {'type': 'SECONDARY', 'title': 'With Concomitant Partial Meniscectomy: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Agili-C™', 'description': 'Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach'}, {'id': 'OG001', 'title': 'Surgical Standard of Care (SSOC)', 'description': 'Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).'}], 'classes': [{'title': 'Change from Baseline to 36 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.0', 'spread': '22.3', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '86.4'}, {'value': '21.9', 'spread': '211.3', 'groupId': 'OG001', 'lowerLimit': '-6.6', 'upperLimit': '54.9'}]}]}, {'title': 'Change from Baseline to 48 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.4', 'spread': '22.4', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '86.4'}, {'value': '22.2', 'spread': '20.6', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '53.5'}]}]}, {'title': 'Change from Baseline to 60 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.1', 'spread': '26.1', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '86.4'}, {'value': '21.3', 'spread': '21.4', 'groupId': 'OG001', 'lowerLimit': '-0.6', 'upperLimit': '53.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 36 Months, 48 Months, and 60 Months', 'description': 'Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants categorized by a meniscus status of concomitant partial meniscectomy (i.e., with a concomitant meniscectomy) was measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline. Number analyzed in each row indicates only participants in the meniscus status specified with data collected for the time frame indicated.'}, {'type': 'SECONDARY', 'title': 'Active Pre-injury: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Agili-C™', 'description': 'Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach'}, {'id': 'OG001', 'title': 'Surgical Standard of Care (SSOC)', 'description': 'Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).'}], 'classes': [{'title': 'Change from Baseline to 36 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39.6', 'spread': '21.0', 'groupId': 'OG000', 'lowerLimit': '-6.8', 'upperLimit': '86.4'}, {'value': '20.2', 'spread': '19.1', 'groupId': 'OG001', 'lowerLimit': '-6.6', 'upperLimit': '54.9'}]}]}, {'title': 'Change from Baseline to 48 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40.4', 'spread': '21.1', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '86.4'}, {'value': '17.4', 'spread': '20.2', 'groupId': 'OG001', 'lowerLimit': '-29.6', 'upperLimit': '59.5'}]}]}, {'title': 'Change from Baseline to 60 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.0', 'spread': '22.3', 'groupId': 'OG000', 'lowerLimit': '-2.5', 'upperLimit': '86.4'}, {'value': '17.5', 'spread': '21.1', 'groupId': 'OG001', 'lowerLimit': '-26.9', 'upperLimit': '64.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 36 Months, 48 Months, and 60 Months', 'description': 'Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants categorized as active prior to injury (based on Tegner score) was measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline. Number analyzed in each row indicates only participants categorized as active pre-injury based on Tegner score with data collected for the time frame indicated.'}, {'type': 'SECONDARY', 'title': 'Non-Active Pre-injury: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Agili-C™', 'description': 'Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach'}, {'id': 'OG001', 'title': 'Surgical Standard of Care (SSOC)', 'description': 'Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).'}], 'classes': [{'title': 'Change from Baseline to 36 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.4', 'spread': '21.2', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '79.5'}, {'value': '17.1', 'spread': '19.8', 'groupId': 'OG001', 'lowerLimit': '-7.8', 'upperLimit': '55.7'}]}]}, {'title': 'Change from Baseline to 48 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.0', 'spread': '22.9', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '79.8'}, {'value': '17.1', 'spread': '19.8', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '56.1'}]}]}, {'title': 'Change from Baseline to 60 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.0', 'spread': '27.2', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '81.7'}, {'value': '15.6', 'spread': '19.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '56.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 36 Months, 48 Months, and 60 Months', 'description': 'Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants categorized as non-active prior to injury (based on Tegner score) was measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline. Number analyzed in each row indicates only participants categorized as non-active pre-injury based on Tegner score with data collected for the time frame indicated.'}, {'type': 'PRIMARY', 'title': 'Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 60 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Agili-C™', 'description': 'Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach'}, {'id': 'OG001', 'title': 'Surgical Standard of Care (SSOC)', 'description': 'Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).'}], 'classes': [{'categories': [{'measurements': [{'value': '38.75', 'groupId': 'OG000', 'lowerLimit': '35.22', 'upperLimit': '42.25'}, {'value': '19.52', 'groupId': 'OG001', 'lowerLimit': '14.40', 'upperLimit': '24.72'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 60 Months', 'description': 'Change from Baseline to 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).\n\nThe change from baseline score is reported as the mean of posterior distribution with 95% credible interval using the Bayesian model.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline for the specified time frame.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Agili-C™', 'description': 'Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach'}, {'id': 'FG001', 'title': 'Surgical Standard 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'FG001', 'numSubjects': '9'}]}, {'type': 'Changes in study team and government regulations', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Participant underwent surgical intervention in the index knee', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '251', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Agili-C™', 'description': 'Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach'}, {'id': 'BG001', 'title': 'Surgical Standard of Care (SSOC)', 'description': 'Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age Category', 'categories': [{'title': '≥50', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}, {'title': '<50', 'measurements': [{'value': '127', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '177', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants categorized by age in years as either ≥50 or \\<50', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Customized', 'classes': [{'title': 'Age Group', 'categories': [{'title': '21 to <45 (Young adulthood)', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}]}, {'title': '45 to <65 (Middle adulthood)', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}, {'title': '≥65 (Elderly)', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants were categorized by age group as one of the following:\n\n* 21 to \\<45 (Young adulthood)\n* 45 to \\<65 (Middle adulthood)\n* ≥65 (Elderly)', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '164', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '246', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'White', 'measurements': [{'value': '159', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '240', 'groupId': 'BG002'}]}, {'title': 'Black', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'Serbia', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI) ≥30', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '187', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants with body mass index (BMI) greater than or equal to 30 kg/m²(Yes/No).', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Safety Analysis Set included randomized participants that received treatment with Agili-C™ or Surgical Standard of Care (SSOC).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-29', 'size': 6301110, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-08-05T14:57', 'hasProtocol': True}, {'date': '2020-04-01', 'size': 935733, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-12-02T16:28', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open-Label, adaptive design with interim analyses'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Open-label Randomized Controlled Trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 251}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-11-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2017-09-14', 'resultsFirstSubmitDate': '2025-11-14', 'studyFirstSubmitQcDate': '2017-10-02', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-12-02', 'studyFirstPostDateStruct': {'date': '2017-10-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-11-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 60 Months', 'timeFrame': 'Baseline, 60 Months', 'description': 'Change from Baseline to 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).\n\nThe change from baseline score is reported as the mean of posterior distribution with 95% credible interval using the Bayesian model.'}], 'secondaryOutcomes': [{'measure': 'Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score Change From Baseline to 60 Months', 'timeFrame': 'Baseline, 60 Months', 'description': 'Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score consists of 9 items. A Likert scale is used with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Scores are transformed to a 0 to 100 scale, with 0 representing a worse outcome and 100 representing a better outcome.\n\nThe change from baseline score is reported as the mean of posterior distribution with 95% credible interval using the Bayesian model.'}, {'measure': 'Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QOL) Score Change From Baseline to 60 Months', 'timeFrame': 'Baseline, 60 Months', 'description': 'Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QOL) Score consists of 4 items. A Likert scale is used with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Scores are transformed to a 0 to 100 scale, with 0 representing a worse outcome and 100 representing a better outcome.\n\nThe change from baseline score is reported as the mean of posterior distribution with 95% credible interval using the Bayesian model.'}, {'measure': 'Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Daily Living (ADL) Score Change From Baseline to 60 Months', 'timeFrame': 'Baseline, 60 Months', 'description': 'Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Daily Living (ADL) Score consists of 17 items. A Likert scale is used with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Scores are transformed to a 0 to 100 scale, with 0 representing a worse outcome and 100 representing a better outcome.\n\nThe change from baseline score is reported as the mean of posterior distribution with 95% credible interval using the Bayesian model.'}, {'measure': 'Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptoms Score Change From Baseline to 60 Months', 'timeFrame': 'Baseline, 60 Months', 'description': 'Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptoms Score consists of 7 items. A Likert scale is used with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Scores are transformed to a 0 to 100 scale, with 0 representing a worse outcome and 100 representing a better outcome.\n\nThe change from baseline score is reported as the mean of posterior distribution with 95% credible interval using the Bayesian model.'}, {'measure': 'Knee Injury and Osteoarthritis Outcome Score (KOOS) Sports Score Change From Baseline to 60 Months', 'timeFrame': 'Baseline, 60 Months', 'description': 'Knee Injury and Osteoarthritis Outcome Score (KOOS) Sports Score consists of 5 items. A Likert scale is used with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Scores are transformed to a 0 to 100 scale, with 0 representing a worse outcome and 100 representing a better outcome.\n\nThe change from baseline score is reported as the mean of posterior distribution with 95% credible interval using the Bayesian model.'}, {'measure': 'Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score Responder Rate Change From Baseline to 60 Months', 'timeFrame': 'Baseline, 60 Months', 'description': 'Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score consists of 5 subscales. A Likert scale is used with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Subscale scores are combined to produce the Overall Score that is transformed to a 0 to 100 scale, with 0 representing a worse outcome and 100 representing a better outcome. Responder rate was defined as the proportion of participants achieving ≥30-point improvement from baseline to 60 months in the KOOS Overall Score.\n\nThe change from baseline data is reported as the mean of posterior distribution with 95% credible interval using the Bayesian model.'}, {'measure': 'Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months and 48 Months', 'timeFrame': 'Baseline, 36 Months, and 48 Months', 'description': 'Change from Baseline to 36 Months and 48 months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).'}, {'measure': 'International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score Change From Baseline to 36 Months, 48 Months, and 60 Months', 'timeFrame': 'Baseline, 36 Months, 48 Months, and 60 Months', 'description': 'Change from Baseline to 36 Months, 48 Months, and 60 Months in the International Knee Documentation Committee (IKDC) Subjective Evaluation score. The IKDC Score was developed to detect improvement or deterioration in symptoms, function, and sports activities due to knee impairment, including patients with meniscal injuries. The possible score ranges from 0 to 100, with a higher score indicating no limitation with daily or sporting activities and the absence of symptoms (i.e., a better outcome).'}, {'measure': 'Tegner Activity Scale Change From Baseline to 36 Months, 48 Months, and 60 Months', 'timeFrame': 'Baseline, 36 Months, 48 Months, and 60 Months', 'description': 'Change from Baseline to 36 Months, 48 Months, and 60 Months in Tegner activity scale. The Tegner activity scale was designed as a score of activity level to complement other functional scores for patients with ligamentous injuries. The Tegner activity scale is a numerical scale ranging from 0 to 10, with a higher score indicating higher levels of activity (i.e., a better outcome).'}, {'measure': 'Short Form Survey (SF-12) Physical Component Score Change From Baseline to 36 Months, 48 Months, and 60 Months', 'timeFrame': 'Baseline, 36 Months, 48 Months, and 60 Months', 'description': 'Change from Baseline to 36 Months, 48 Months, and 60 Months in SF-12 Physical Component Score. The SF-12 Physical Component Score assesses health related quality of life. The score is on a scale ranging from 0 to 100, with a higher score indicating a better outcome.'}, {'measure': 'Short Form Survey (SF-12) Mental Component Score Change From Baseline to 36 Months, 48 Months, and 60 Months', 'timeFrame': 'Baseline, 36 Months, 48 Months, and 60 Months', 'description': 'Change from Baseline to 36 Months, 48 Months, and 60 Months in SF-12 Mental Component Score. The SF-12 Mental Component Score assesses mental health and well-being. The score is on a scale ranging from 0 to 100, with a higher score indicating a better outcome.'}, {'measure': 'Chondral Lesions: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months', 'timeFrame': 'Baseline, 36 Months, 48 Months, and 60 Months', 'description': 'Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants with Chondral Lesions measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).'}, {'measure': 'Osteochondral Lesions: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months', 'timeFrame': 'Baseline, 36 Months, 48 Months, and 60 Months', 'description': 'Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants with Osteochondral Lesions measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).'}, {'measure': 'Single Lesion: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months', 'timeFrame': 'Baseline, 36 Months, 48 Months, and 60 Months', 'description': 'Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants with a Single Lesion measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).'}, {'measure': 'Multiple Lesions: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months', 'timeFrame': 'Baseline, 36 Months, 48 Months, and 60 Months', 'description': 'Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants with Multiple Lesions measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).'}, {'measure': 'Level of Osteoarthritis (Kellgren-Lawrence Grade 0-1): Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months', 'timeFrame': 'Baseline, 36 Months, 48 Months, and 60 Months', 'description': 'Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants based on their level of osteoarthritis measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).\n\nParticipants were categorized as without osteoarthritis based on Kellgren-Lawrence (K/L) grade of 0 to 1. K/L grading included Grade 0 (No evidence of osteoarthritis), Grade 1 (Doubtful), Grade 2 (Minimal), and Grade 3 (Moderate).'}, {'measure': 'Level of Osteoarthritis (Kellgren-Lawrence Grade 2-3): Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months', 'timeFrame': 'Baseline, 36 Months, 48 Months, and 60 Months', 'description': 'Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants based on their level of osteoarthritis measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).\n\nParticipants categorized with osteoarthritis based on Kellgren-Lawrence (K/L) grade of 2 to 3. K/L grading included Grade 0 (No evidence of osteoarthritis), Grade 1 (Doubtful), Grade 2 (Minimal), or Grade 3 (Moderate).'}, {'measure': 'Total Lesion Area ≤3cm²: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months', 'timeFrame': 'Baseline, 36 Months, 48 Months, and 60 Months', 'description': 'Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants with a lesion area ≤3cm² measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).'}, {'measure': 'Total Lesion Area >3cm²: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months', 'timeFrame': 'Baseline, 36 Months, 48 Months, and 60 Months', 'description': 'Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants with a lesion area \\>3cm² measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).'}, {'measure': 'Without Previous Ligament Reconstruction: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months', 'timeFrame': 'Baseline, 36 Months, 48 Months, and 60 Months', 'description': 'Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants without previous ligament reconstruction was measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).'}, {'measure': 'With Previous Ligament Reconstruction: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months', 'timeFrame': 'Baseline, 36 Months, 48 Months, and 60 Months', 'description': 'Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants with previous ligament reconstruction was measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).'}, {'measure': 'With Intact Meniscus: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months', 'timeFrame': 'Baseline, 36 Months, 48 Months, and 60 Months', 'description': 'Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants categorized by a meniscus status of intact meniscus (i.e., without a concomitant meniscectomy) was measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).'}, {'measure': 'With Previous Partial Meniscectomy: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months', 'timeFrame': 'Baseline, 36 Months, 48 Months, and 60 Months', 'description': 'Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants categorized by a meniscus status of previous partial meniscectomy (i.e., with a prior meniscectomy) was measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).'}, {'measure': 'With Concomitant Partial Meniscectomy: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months', 'timeFrame': 'Baseline, 36 Months, 48 Months, and 60 Months', 'description': 'Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants categorized by a meniscus status of concomitant partial meniscectomy (i.e., with a concomitant meniscectomy) was measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).'}, {'measure': 'Active Pre-injury: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months', 'timeFrame': 'Baseline, 36 Months, 48 Months, and 60 Months', 'description': 'Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants categorized as active prior to injury (based on Tegner score) was measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).'}, {'measure': 'Non-Active Pre-injury: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months', 'timeFrame': 'Baseline, 36 Months, 48 Months, and 60 Months', 'description': 'Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants categorized as non-active prior to injury (based on Tegner score) was measured by the five subscales of Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Cartilage or Osteochondral Defects in the Knee', 'Up to Moderate Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '40080289', 'type': 'DERIVED', 'citation': "Kon E, De Caro F, Dasa V, M Scopp J, Di Matteo B, Flanigan D, Shabshin N, Strickland S, Altschuler N. Female patients report comparable results to males after the implantation of an aragonite-based scaffold for the treatment of knee chondral and osteochondral defects: a gender-based analysis of a RCT at 4 years' follow-up. J Orthop Traumatol. 2025 Mar 13;26(1):17. doi: 10.1186/s10195-025-00829-y."}, {'pmid': '36779614', 'type': 'DERIVED', 'citation': 'Altschuler N, Zaslav KR, Di Matteo B, Sherman SL, Gomoll AH, Hacker SA, Verdonk P, Dulic O, Patrascu JM, Levy AS, Robinson D, Kon E. Aragonite-Based Scaffold Versus Microfracture and Debridement for the Treatment of Knee Chondral and Osteochondral Lesions: Results of a Multicenter Randomized Controlled Trial. Am J Sports Med. 2023 Mar;51(4):957-967. doi: 10.1177/03635465231151252. Epub 2023 Feb 13.'}]}, 'descriptionModule': {'briefSummary': 'The current study compares the efficacy and safety of the Agili-C implant to Surgical Standard of Care treatment in patients suffering from joint surface lesions of the knee. The patient population is heterogeneous, involving different kinds of joint surface lesions: focal cartilage lesions, osteochondral defects and mild to moderate osteoarthritis, including multiple defects.', 'detailedDescription': "This is a prospective, multicenter, open-label, randomized, and controlled trial of Agili-C™ vs. SSOC for the repair of joint surface lesions.\n\nFollow-up visits will be performed at 2 weeks and at 3, 6, 12, 18, 24, 36, 48 and 60 months post-procedure to evaluate the patient's knee condition and clinical health.\n\nThe following questionnaires: KOOS, IKDC Knee Examination Form 2000, IKDC Subjective Knee Evaluation , SF-12 Health Survey, Tegner Activity Score will be completed at baseline and at 6, 12, 18, 24, 36, 48 and 60 months.\n\nAnterior-Posterior (A/P) and Lateral knee X-rays will be taken at 2 weeks and at 6, 12, 18 24, 36, 48 and 60 months post procedure. MRI according to specific protocol will be performed at 12 and 24 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 21 -75 years\n2. Up to 3 treatable joint surface lesion(s), ICRS Grade III or above, on the femoral condyles and/or trochlea\n3. Symptomatic total treatable area 1-7 cm2. Asymptomatic lesions will not be included in the calculation\n4. Must be physically and mentally willing and able to comply with the post-operative rehabilitation protocol and scheduled clinical and radiographic visits\n5. Signed and dated the IRB/Ethics Committee approved Informed Consent Form and HIPPA (if applicable)\n6. Non-responsive to physical therapy for at least 3-4 weeks\n\nExclusion Criteria:\n\n1. KOOS Pain Subscale score at baseline is less than 20 or more than 65 (scale: maximum pain =0, pain free =100)\n2. Bony defect depth deeper than 8mm, according to baseline MRI/X-ray/arthroscopy\n3. Articular cartilage lesions in the tibia or the patella, ICRS grades IVa or above\n4. Osteoarthritis of the index knee graded 4 according to the Kellgren-Lawrence Grading\n5. Significant instability of the index knee according to IKDC Knee Examination Form 2000, Grade C (abnormal) or D (severely abnormal)\n6. Malalignment more than 8 degrees varus OR 8 degrees valgus according to standing X-ray\n7. Lack of functional remaining meniscus, at least 5mm rim at the end of the procedure\n8. Meniscal transplantation in the past 6 months\n9. Any known tumor of the index knee\n10. Any known history of intra-articular or osseous infection of the index knee\n11. Any evidence of active infection anywhere in the body. Urinary Tract Infection (UTI) patients can be included following antibiotic treatment, and provided that two consecutive cultures are negative (taken within at least 2 weeks of each other)\n12. Any known history of inflammatory arthropathy or crystal-deposition arthropathy\n13. Any known systemic cartilage and/or bone disorder, such as but not limited to, osteoporosis, chondrodysplasia or osteogenesis imperfecta\n14. Body Mass Index (BMI) \\> 35\n15. Chemotherapy in the past 12 months\n16. Any previous surgical cartilage treatment (such as: microfracture, ACI, OATS, etc.) in the index knee within the last 6 months\n17. Any previous ligamentous repair or malalignment correction in the index knee within the last 6 months\n18. History of allergic reaction or intolerance of materials containing calcium carbonate or hyaluronate\n19. Patient who is pregnant or intends to become pregnant during the study\n20. History of any significant systemic disease, such as but not limited to: HIV, hepatitis, HTLV, syphilis, and coagulopathies\n21. Known substance or alcohol abuse\n22. Participation in other clinical trials within 60 days prior to the study or concurrent with the study\n23. Known insulin dependent diabetes mellitus\n24. Unable to undergo either MRI or X-ray\n25. Use of anticoagulation medication or antiaggregant medication; however up to 100 mg Acetylsalicylic acid (ASA) daily is allowed\n26. Previous intra-articular steroid injection within the last 1 month\n27. Prisoners\n28. Uncontained lesion - Lack of vital bone wall, at least 2mm thick, completely surrounding the lesion - based on MRI/X-ray/arthroscopy\n29. Inability to position the implant 2mm recessed relative to the articular surface - based on MRI/X-ray/arthroscopy'}, 'identificationModule': {'nctId': 'NCT03299959', 'briefTitle': 'Agili-C™ Implant Performance Evaluation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Smith & Nephew, Inc.'}, 'officialTitle': 'A Prospective Multicenter Open-label Randomized Controlled Trial of Agili-C™ vs. Surgical Standard of Care (SSOC) for the Treatment of Joint Surface Lesions of the Knee', 'orgStudyIdInfo': {'id': 'CLN0021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Agili-C', 'interventionNames': ['Device: Agili-C implant']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Surgical Standard of Care (SSOC)', 'interventionNames': ['Procedure: SSOC']}], 'interventions': [{'name': 'Agili-C implant', 'type': 'DEVICE', 'description': 'Agili-C implant', 'armGroupLabels': ['Agili-C']}, {'name': 'SSOC', 'type': 'PROCEDURE', 'description': 'microfracture and/or debridement', 'armGroupLabels': ['Surgical Standard of Care (SSOC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91942', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Horizon Clinical Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'LSU Healthcare Network Orthopedic & Sports Medicine', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '21804', 'city': 'Salisbury', 'state': 'Maryland', 'country': 'United States', 'facility': 'Peninsula Orthopaedic Associates', 'geoPoint': {'lat': 38.36067, 'lon': -75.59937}}, {'zip': '02467', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '65212', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Missouri, Missouri Orthopaedic Institute', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Orthopedic Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Hospital for Special Surgery', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University, Wexner Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '76015', 'city': 'Arlington', 'state': 'Texas', 'country': 'United States', 'facility': 'Arlington Orthopedic Associates', 'geoPoint': {'lat': 32.73569, 'lon': -97.10807}}, {'zip': '23294', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'OrthoVirginia', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'city': 'Antwerp', 'country': 'Belgium', 'facility': 'AZ Monica', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '1114', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Uzsoki Utcai Kórház', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '2892', 'city': 'Tata', 'country': 'Hungary', 'facility': 'Kastélypark Klinika', 'geoPoint': {'lat': 47.65289, 'lon': 18.31838}}, {'zip': '60930', 'city': 'Be’er Ya‘aqov', 'country': 'Israel', 'facility': 'Assaf Harofeh Medical Center', 'geoPoint': {'lat': 31.93864, 'lon': 34.83749}}, {'zip': '3436212', 'city': 'Haifa', 'country': 'Israel', 'facility': '"Carmel" Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Medical Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'Hasharon Hospital, Petach Tikva', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'zip': '6423906', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Souraski Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'city': 'Bergamo', 'country': 'Italy', 'facility': 'Humanitas Gavazzeni', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'city': 'Rozzano', 'country': 'Italy', 'facility': 'Istituto Clinico Humanitas', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'city': 'Krakow', 'country': 'Poland', 'facility': 'Specialist Hospital. 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