Viewing Study NCT03485157

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Ignite Creation Date: 2025-12-24 @ 6:55 PM
Ignite Modification Date: 2026-01-03 @ 10:00 PM
Study NCT ID: NCT03485157
Status: COMPLETED
Last Update Posted: 2023-12-11
First Post: 2018-03-20
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Micronized dHACM vs. Saline in the Treatment of Osteoarthritis of the Knee
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-06-26', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'CTInquiries@mimedx.com', 'phone': '(770) 651-9100', 'title': 'Chief Medical Officer', 'organization': 'MIMEDX'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were collects for 1 year in the double blinded study and 6 months in the Open Label Study.', 'eventGroups': [{'id': 'EG000', 'title': 'Micronized dHACM', 'description': 'Injection of micronized dHACM\n\nMicronized dHACM: Injection of 40 mg micronized dehydrated human amnion chorion membrane (dHACM) suspended in 1 mL 0.9% Sodium Chloride, USP', 'otherNumAtRisk': 223, 'deathsNumAtRisk': 223, 'otherNumAffected': 123, 'seriousNumAtRisk': 223, 'deathsNumAffected': 0, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'Saline', 'description': 'Injection of 0.9% Sodium Chloride Injection, USP\n\nSaline: Injection of 1 mL 0.9% Sodium Chloride, USP', 'otherNumAtRisk': 224, 'deathsNumAtRisk': 224, 'otherNumAffected': 120, 'seriousNumAtRisk': 224, 'deathsNumAffected': 0, 'seriousNumAffected': 12}, {'id': 'EG002', 'title': 'Open-Label Micronized dHACM', 'description': 'Open-label injection of micronized dHACM\n\nMicronized dHACM: Injection of 40 mg micronized dehydrated human amnion chorion membrane (dHACM) suspended in 1 mL 0.9% Sodium Chloride, USP', 'otherNumAtRisk': 217, 'deathsNumAtRisk': 217, 'otherNumAffected': 94, 'seriousNumAtRisk': 217, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 49}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 29}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Joint effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Joint noise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Synovial cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Intervertebral disc degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Plantar fasciitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tendonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Joint stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cervical spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': "Dupuytren's contracture", 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Foot deformity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Mobility decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pain in jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tenosynovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Trigger finger', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injection site joint pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injection site joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injection site oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injection site mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Joint injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Meniscus injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tooth fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Animal bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Face injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Iliotibial band syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 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'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Removal by PI', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Screening visit occurred after enrollment and could possibly be the same day as randomization/treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'BG000'}, {'value': '224', 'groupId': 'BG001'}, {'value': '447', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Micronized dHACM', 'description': 'Injection of micronized 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'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '187', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '211', 'groupId': 'BG000'}, {'value': '212', 'groupId': 'BG001'}, {'value': '423', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, 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'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height (in)', 'classes': [{'categories': [{'measurements': [{'value': '67.17', 'spread': '4.114', 'groupId': 'BG000'}, {'value': '66.72', 'spread': '3.748', 'groupId': 'BG001'}, {'value': '66.94', 'spread': '3.937', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Inches', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '187.22', 'spread': '39.629', 'groupId': 'BG000'}, {'value': '185.12', 'spread': '40.305', 'groupId': 'BG001'}, {'value': '186.17', 'spread': '39.938', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'lbs', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '29.74', 'spread': '4.919', 'groupId': 'BG000'}, {'value': '29.81', 'spread': '5.279', 'groupId': 'BG001'}, {'value': '29.77', 'spread': '5.097', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Demographic and baseline characteristics of subjects in the ITT Set.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-01-31', 'size': 237176, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_004.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-12-06T12:11', 'hasProtocol': True}, {'date': '2020-06-24', 'size': 515432, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_005.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-12-06T12:11', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 447}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2022-04-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-07', 'studyFirstSubmitDate': '2018-03-20', 'resultsFirstSubmitDate': '2023-05-31', 'studyFirstSubmitQcDate': '2018-03-26', 'lastUpdatePostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-12-07', 'studyFirstPostDateStruct': {'date': '2018-04-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Exploratory Endpoint: Change From Baseline in the Visual Analog Scale (VAS) for Pain at 270, and 365 Days', 'timeFrame': 'Up to 365 days', 'description': 'VAS: 0 to 100 mm horizontal visual analog scale with a higher score indicating greater pain'}, {'measure': 'Exploratory Endpoint: Change From Baseline in the WOMAC Scores at 270 and 365 Days', 'timeFrame': 'Up to 365 days', 'description': 'Western Ontario and McMaster Universities Arthritis Index (WOMAC) evaluation of Hip and Knee Osteoarthritis. Self-administered questionnaire consisting of 24 questions divided into 3 subscales:\n\n* Pain (5 questions)\n* Stiffness (2 questions)\n* Physical Function (17 questions)\n\nThe test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).\n\nThe scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. A sum of the scores for all three subscales gives a total WOMAC score, with a possible total score range of 0-96.\n\nHigher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.'}, {'measure': 'Exploratory Endpoint: Change From Baseline in the Visual Analog Scale (VAS) for Satisfaction at 90, 180, 270 and 365 Days', 'timeFrame': 'Up to 365 days', 'description': 'VAS: 0 to 100 mm horizontal visual analog scale with a higher score indicating greater satisfaction'}, {'measure': 'Exploratory Endpoint: Change From Baseline in the KOOS Scores at 90, 180, 270, and 365 Days', 'timeFrame': 'Up to 365 days', 'description': 'Knee Injury and Osteoarthritis Outcome Score (KOOS): 5 subscales scored on a 5 point scale where the final score is summed and transformed into a 100 point scale with a higher score representing no disability and a lower score representing extreme disability'}], 'primaryOutcomes': [{'measure': 'Primary Efficacy Endpoint: Change From Baseline in Visual Analog Scale (VAS) for Pain at 90 Days', 'timeFrame': '90 days', 'description': 'Visual Analog Scale (VAS): 0 to 100 mm horizontal visual analog scale with a higher score indicating greater pain'}, {'measure': 'Primary Efficacy Endpoint: Change From Baseline in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at 90 Days', 'timeFrame': '90 days', 'description': 'Western Ontario and McMaster Universities Arthritis Index (WOMAC) evaluation of Hip and Knee Osteoarthritis. Self-administered questionnaire consisting of 24 questions divided into 3 subscales:\n\n* Pain (5 questions)\n* Stiffness (2 questions)\n* Physical Function (17 questions)\n\nThe test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).\n\nThe scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. A sum of the scores for all three subscales gives a total WOMAC score, with a possible total score range of 0-96.\n\nHigher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.'}, {'measure': 'Primary Safety Endpoint: Number of Participants With Adverse Events (AEs)', 'timeFrame': '365 days', 'description': 'Number of Participants with At Least 1 Treatment Emergent Adverse Event (TEAE) Reported'}, {'measure': 'Primary Safety Endpoint: Number of Participants With Serious Adverse Events (SAEs)', 'timeFrame': '365 days', 'description': 'Number of Participants with At Least 1 Serious Treatment Emergent Adverse Event (TEAE) Reported'}, {'measure': 'Primary Safety Endpoint: Number of Participants With Unanticipated Adverse Events', 'timeFrame': '365 days', 'description': 'Number of Participants with At Least 1 Unanticipated Treatment Emergent Adverse Event (TEAE) Reported'}], 'secondaryOutcomes': [{'measure': 'Secondary Endpoint: Change From Baseline in Visual Analog Scale (VAS) at 180 Days', 'timeFrame': '180 days', 'description': 'Visual Analog Scale (VAS) : 0 to 100 mm horizontal visual analog scale with a higher score indicating greater pain'}, {'measure': 'Secondary Endpoint:Change From Baseline in WOMAC at 180 Days', 'timeFrame': '180 days', 'description': 'Western Ontario and McMaster Universities Arthritis Index (WOMAC) evaluation of Hip and Knee Osteoarthritis. Self-administered questionnaire consisting of 24 questions divided into 3 subscales:\n\n* Pain (5 questions)\n* Stiffness (2 questions)\n* Physical Function (17 questions)\n\nThe test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).\n\nThe scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. A sum of the scores for all three subscales gives a total WOMAC score, with a possible total score range of 0-96.\n\nHigher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety and effectiveness of micronized dehydrated human amnion chorion membrane as compared to the 0.9% Sodium Chloride Injection, USP placebo control for the treatment of knee osteoarthritis', 'detailedDescription': 'Each subject will receive 1 injection (micronized dHACM or placebo) and be evaluated for efficacy and safety during a 12-month observation period. A second injection (open-label access to micronized dHACM) will be offered to all subjects at the 180-day, 270-day, and 365-day time points, it may only be used once. Blinding for the first injection treatment allocation will be maintained until the end of the study.\n\nSubjects who receive the open-label access treatment will continue to be followed for 180 days after this second injection, regardless of the time at which treatment was received.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age ≥ 21 and ≤ 80 years\n2. Subject has a diagnosis of osteoarthritis (OA) defined as Grade 1 to 3 on the Kellgren Lawrence grading scale\n3. Subject is willing and able provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study\n4. Subject must have a VAS pain scale greater than 45\n\nExclusion Criteria:\n\n1. Subject has a diagnosis of osteoarthritis (OA) defined as Grade 4 on the Kellgren Lawrence grading scale\n2. BMI greater than 40 kg/m\\^2\n3. Subject has active infection at the injection site\n4. Symptomatic OA of the contralateral knee or of either hip that is not responsive to acetaminophen (Tylenol®) and requires other therapy.\n5. Subject has rheumatoid arthritis, psoriatic arthritis, or have been diagnosed with any other disorders that is the primary source of their knee pain, including but not limited to: osteonecrosis, radiculopathy, bursitis, tendinitis, tumor, cancer\n6. Subject has documented history of gout or pseudo-gout\n7. Subject has autoimmune disease or a known history of having Acquired Immunodeficiency Syndromes (AIDS) or HIV\n8. Subject has received any of the following to the target knee:\n\n 1. Intra-articular hyaluronic acid (HA) injection within 12 weeks prior to screening\n 2. Steroid or platelet rich plasma (PRP) injection within 12 weeks prior to screening\n 3. Has had or is planning to have major surgery or arthroscopy in the target knee within 26 weeks of treatment\n 4. History of a total knee arthroplasty\n9. Subject has used an investigational drug, device or biologic within 12 weeks prior to treatment\n10. Subject has a history of immunosuppressive or chemotherapy in the last 5 years\n11. Subject has had prior radiation at the site\n12. Subject is currently taking anticoagulant therapy (excluding Plavix or Aspirin)\n13. Subject is pregnant or plans to become pregnant within 365 days of treatment\n14. Subject has any significant medical condition that, in the opinion of the Investigator, would interfere with protocol evaluation and participation\n15. Subject is a worker's compensation patient\n16. Subject is a prisoner"}, 'identificationModule': {'nctId': 'NCT03485157', 'briefTitle': 'Micronized dHACM vs. Saline in the Treatment of Osteoarthritis of the Knee', 'organization': {'class': 'INDUSTRY', 'fullName': 'MiMedx Group, Inc.'}, 'officialTitle': 'A Phase 2B, Prospective, Double-blinded, Randomized Controlled Trial of the Micronized Dehydrated Human Amnion Chorion Membrane Injection as Compared to Saline Placebo Injection in the Treatment of Osteoarthritis of the Knee', 'orgStudyIdInfo': {'id': 'AIOA001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Micronized dHACM', 'description': 'Injection of micronized dHACM', 'interventionNames': ['Biological: Micronized dHACM']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline', 'description': 'Injection of 0.9% Sodium Chloride Injection, USP', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'Micronized dHACM', 'type': 'BIOLOGICAL', 'description': 'Injection of 40 mg micronized dehydrated human amnion chorion membrane (dHACM) suspended in 1 mL 0.9% Sodium Chloride, USP', 'armGroupLabels': ['Micronized dHACM']}, {'name': 'Saline', 'type': 'DRUG', 'description': 'Injection of 1 mL 0.9% Sodium Chloride, USP', 'armGroupLabels': ['Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Central Research Associates, Inc', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85283', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Fiel Family and Sports Medicine', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Horizon Clinical Research', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '06030', 'city': 'Farmington', 'state': 'Connecticut', 'country': 'United States', 'facility': 'UConn Health', 'geoPoint': {'lat': 41.71982, 'lon': -72.83204}}, {'zip': '06106', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Bone & Joint Inst. at Hartford Hospital', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '34232', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Gulfcoast Research Institute', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '30327', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Paragon Sports Medicine', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60521', 'city': 'Hinsdale', 'state': 'Illinois', 'country': 'United States', 'facility': 'Hinsdale Orthopedics', 'geoPoint': {'lat': 41.80086, 'lon': -87.93701}}, {'zip': '21046', 'city': 'Columbia', 'state': 'Maryland', 'country': 'United States', 'facility': 'Arthritis Care Specialist of Maryland', 'geoPoint': {'lat': 39.24038, 'lon': -76.83942}}, {'zip': '48106', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'MedSport', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27704', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Reseach', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Research', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '16602', 'city': 'Altoona', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University Orthopedics Center', 'geoPoint': {'lat': 40.51868, 'lon': -78.39474}}, {'zip': '16801', 'city': 'State College', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University Orthopedics Center', 'geoPoint': {'lat': 40.79339, 'lon': -77.86}}, {'zip': '78234', 'city': 'Fort Sam Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'SAMMC', 'geoPoint': {'lat': 29.45303, 'lon': -98.4417}}, {'zip': '23294', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Ortho Virginia', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Alfred C Gellhorn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Esprit R&D Associate GSK'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MiMedx Group, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}