Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-02-22 @ 7:04 AM
Study NCT ID:
NCT02983292
Status:
COMPLETED
Last Update Posted:
2024-11-04
First Post:
2016-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PyroTITAN Humeral Resurfacing Arthroplasty (HRA)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001168', 'term': 'Arthritis'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'manvendra.saxena@smith-nephew.com', 'phone': '+61 455 870 175', 'title': 'Dr. Manvendra Saxena', 'organization': 'Senior Specialist-Clinical Study Management'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Surgery to end of study visit, up to 5 years', 'description': 'All postoperative device-related \\& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \\& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.', 'eventGroups': [{'id': 'EG000', 'title': 'PyroTITAN™ HRA Shoulder System', 'description': 'Participants implanted with PyroTITAN™ Humeral Resurfacing Arthroplasty (HRA) Shoulder System', 'otherNumAtRisk': 137, 'deathsNumAtRisk': 137, 'otherNumAffected': 12, 'seriousNumAtRisk': 137, 'deathsNumAffected': 1, 'seriousNumAffected': 47}], 'otherEvents': [{'term': 'Minor rotator cuff tendonitis left shoulder.', 'notes': 'Possibly related to procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Suspected stress fracture of posterior glenoid osteophyte right shoulder', 'notes': 'Possibly related to procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bursitis right shoulder', 'notes': 'Possibly related to procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Squeaking right shoulder after physiotherapy.', 'notes': 'Possibly related to procedure or device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cuff pain right shoulder', 'notes': 'Possibly related to procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Suspected rotator cuff tendonitis left shoulder', 'notes': 'Not relate to procedure or device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Suspected rotator cuff tendonitis right.', 'notes': 'Possibly related to procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Crepitation around right shoulder joint with activity', 'notes': 'Possibly related to Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Occasional pain up right arm', 'notes': 'Possibly related to procedure or device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Audible squeaking left pyrotitan shoulder', 'notes': 'Device related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Audible squeak on flexion/extension of operative shoulder', 'notes': 'Device related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Persistent operative shoulder pain', 'notes': 'Possibly related to procedure or device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin irritation of scar in operative shoulder', 'notes': 'Possibly related to procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'right shoulder stiffness', 'notes': 'Possibly related to procedure or device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Right shoulder rotator cuff pain', 'notes': 'Not related to Procedure or Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right shoulder pain', 'notes': 'Device related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Duke C Colon Cancer', 'notes': 'Not related to Procedure or Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urosepsis following surgery for prostate cancer biopsy', 'notes': 'Not related to Procedure or Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Meniscus tear in left knee', 'notes': 'Not related to Procedure or Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'cancerous nodule thyroid', 'notes': 'Not related to Procedure or Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Locking right knee', 'notes': 'Not related to Procedure or Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fractured left scaphoid following a fall.', 'notes': 'Not related to Procedure or Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'worsening OA left knee', 'notes': 'Not related to Procedure or Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Worsening of OA in right knee', 'notes': 'Not related to Procedure or Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain exacerbated', 'notes': 'Not related to Procedure or Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Deterioration of left shoulder secondary to pre-existing condition (avacular necrosis).', 'notes': 'Not related to Procedure or Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thoracic outlet syndrome progression', 'notes': 'Not related to Procedure or Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right shoulder rotator cuff impingement', 'notes': 'Not related to Procedure or Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right shoulder posterior instability', 'notes': 'Not related to Procedure or Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Joint metallosis in right (operative) shoulder', 'notes': 'Possibly related to procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right shoulder OA worsening', 'notes': 'Not related to Procedure or Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Benign prostatic hyperplasia', 'notes': 'Not related to Procedure or Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac chest pain', 'notes': 'Not related to Procedure or Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aggravation of OA in left thumb and wrist', 'notes': 'Not related to Procedure or Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Persistent right rotator cuff pain', 'notes': 'Not related to Procedure or Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anterior shoulder pain due to subscap impingement on the anterior aspect of the hemiarthroplasty', 'notes': 'Not related to Procedure or Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fracture of PyroTITAN prosthesis.', 'notes': 'Device related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis and recurring infection in right knee', 'notes': 'Not related to Procedure or Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Left shoulder rotator cuff tear', 'notes': 'Not related to Procedure or Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Broken right ankle', 'notes': 'Not related to Procedure or Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Undisplaced fracture of implant', 'notes': 'Device related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Worsening of OA in left shoulder', 'notes': 'Not related to Procedure or Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Worsening knee OA and pain', 'notes': 'Not related to Procedure or Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Difficulty with function and ROM in left operative shoulder', 'notes': 'Not related to Procedure or Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ongoing pain in left shoulder', 'notes': 'Not related to Procedure or Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right subscapular bursa irritation.', 'notes': 'Procedure Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right shoulder full thickness tear', 'notes': 'Not related to Procedure or Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right leg cellulitis', 'notes': 'Not related to Procedure or Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rotator cuff tendonitis left shoulder', 'notes': 'Not related to Procedure or Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Exacerbation of OA in right shoulder', 'notes': 'Not related to Procedure or Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Exacerabated right shoulder OA.', 'notes': 'Not related to Procedure or Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis in left leg.', 'notes': 'Not related to Procedure or Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Knife injury to left arm', 'notes': 'Not related to Procedure or Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thoracic outlet syndrome progression.', 'notes': 'Not related to Procedure or Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rotator cuff impingement left shoulder.', 'notes': 'Possibly related to procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'worsening osteoarthritis left wrist', 'notes': 'Not related to Procedure or Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Exacerbation of OA right knee.', 'notes': 'Not related to Procedure or Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Subscapular bursa irritation left shoulder', 'notes': 'Procedure Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fractured prosthesis', 'notes': 'Device related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Worsening left shoulder osteoartritis', 'notes': 'Not related to Procedure or Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ongoing pain in right operative shoulder', 'notes': 'Possibly related to Procedure or Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'worsening Osteoarthritis in right foot', 'notes': 'Not related to Procedure or Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Worsening left shoulder osteoarthritis.', 'notes': 'Not related to Procedure or Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Worsening right shoulder arthritis', 'notes': 'Not related to Procedure or Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Worsenning osteoarthritis bilateral knees.', 'notes': 'Not related to Procedure or Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'notes': 'Not related to Procedure or Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Exacerbation of lower back nerve pain', 'notes': 'Not related to Procedure or Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection left shoulder wound', 'notes': 'Procedure Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Device Survival: Kaplan-Meir Estimate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PyroTITAN™ HRA Shoulder System', 'description': 'Participants implanted with PyroTITAN™ Humeral Resurfacing Arthroplasty (HRA) Shoulder System'}], 'classes': [{'categories': [{'measurements': [{'value': '98.47', 'groupId': 'OG000', 'lowerLimit': '96.35', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Device survival was defined as the absence of device fracture at the two year time-point. Percentage of participants with survival of the device estimated using the Kaplan-Meier method.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data available at the time frame indicated'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Device-Related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PyroTITAN™ HRA Shoulder System', 'description': 'Participants implanted with PyroTITAN™ Humeral Resurfacing Arthroplasty (HRA) Shoulder System'}], 'classes': [{'title': 'Device-Related Non-Serious Adverse Event', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Device-Related Serious Adverse Event', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post-operatively to 5-Years', 'description': 'Count of participants with device-related Non-Serious \\& Serious Adverse Events were the event was related to device use (e.g., component breakage) as determined by investigator assessment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data available at the time frame indicated'}, {'type': 'SECONDARY', 'title': 'Cumulative Device Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PyroTITAN™ HRA Shoulder System', 'description': 'Participants implanted with PyroTITAN™ Humeral Resurfacing Arthroplasty (HRA) Shoulder System'}], 'classes': [{'title': '2-Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '98.5', 'groupId': 'OG000', 'lowerLimit': '96.3', 'upperLimit': '100.0'}]}]}, {'title': '5-Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '97.5', 'groupId': 'OG000', 'lowerLimit': '94.6', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2-Years and 5-Years', 'description': 'Device success was defined as the absence of device fracture over time. Cumulative device success was determined by the percentage of participants with no device fractures by the two year \\& five year time-points.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data available at the time frame indicated'}, {'type': 'SECONDARY', 'title': 'Cumulative Device Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PyroTITAN™ HRA Shoulder System', 'description': 'Participants implanted with PyroTITAN™ Humeral Resurfacing Arthroplasty (HRA) Shoulder System'}], 'classes': [{'title': '2-Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '96.24', 'groupId': 'OG000', 'lowerLimit': '93.01', 'upperLimit': '99.48'}]}]}, {'title': '5-Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '94.17', 'groupId': 'OG000', 'lowerLimit': '89.92', 'upperLimit': '98.42'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2-Years and 5-Years', 'description': 'Device survival was defined as the absence of device revision over time. Cumulative device survival was determined by the percentage of participants with no device revisions by the two year \\& five year time-points.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data available at the time frame indicated'}, {'type': 'SECONDARY', 'title': 'Device Functionality: American Shoulder and Elbow Surgeons (ASES) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PyroTITAN™ HRA Shoulder System', 'description': 'Participants implanted with PyroTITAN™ Humeral Resurfacing Arthroplasty (HRA) Shoulder System'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31.1', 'spread': '19.7', 'groupId': 'OG000'}]}]}, {'title': '2-Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '83.7', 'spread': '18.8', 'groupId': 'OG000'}]}]}, {'title': '5-Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '88.1', 'spread': '16.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2-Years and 5-Years', 'description': 'ASES scores range from 0 to 100, with a score of 0 indicating a worse shoulder condition and 100 indicating the best shoulder condition.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data available at the time frame indicated'}, {'type': 'SECONDARY', 'title': 'Device Functionality: Visual Analog Scale (VAS) - Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PyroTITAN™ HRA Shoulder System', 'description': 'Participants implanted with PyroTITAN™ Humeral Resurfacing Arthroplasty (HRA) Shoulder System'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66', 'spread': '21', 'groupId': 'OG000'}]}]}, {'title': '2-Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.4', 'spread': '17.4', 'groupId': 'OG000'}]}]}, {'title': '5-Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.5', 'spread': '15.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2-Years and 5-Years', 'description': 'The VAS Pain score range was from 0 to 100, with 0 representing no pain and 100 representing the worse possible pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data available at the time frame indicated'}, {'type': 'SECONDARY', 'title': 'Device Functionality: Visual Analog Scale (VAS) - Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PyroTITAN™ HRA Shoulder System', 'description': 'Participants implanted with PyroTITAN™ Humeral Resurfacing Arthroplasty (HRA) Shoulder System'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.6', 'spread': '18.5', 'groupId': 'OG000'}]}]}, {'title': '2-Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '89.6', 'spread': '18.9', 'groupId': 'OG000'}]}]}, {'title': '5-Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92.5', 'spread': '13.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2-Years and 5-Years', 'description': 'The VAS Satisfaction score range was from 0 to 100, with 0 representing the worst result and 100 representing the best result.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data available at the time frame indicated'}, {'type': 'SECONDARY', 'title': 'Device Functionality: Western Ontario Osteoarthritis Score (WOOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PyroTITAN™ HRA Shoulder System', 'description': 'Participants implanted with PyroTITAN™ Humeral Resurfacing Arthroplasty (HRA) Shoulder System'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66.7', 'spread': '14.1', 'groupId': 'OG000'}]}]}, {'title': '2-Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.2', 'spread': '89.1', 'groupId': 'OG000'}]}]}, {'title': '5-Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.6', 'spread': '14.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2-Years and 5-Years', 'description': 'The WOOS score was based on 19 questions ranging from 0 to 100 with 0 being the best result and 100 being the worst result. A lower score indicated a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data available at the time frame indicated'}, {'type': 'SECONDARY', 'title': 'Device Functionality: QuickDASH Outcome Measure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PyroTITAN™ HRA Shoulder System', 'description': 'Participants implanted with PyroTITAN™ Humeral Resurfacing Arthroplasty (HRA) Shoulder System'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '49.5', 'spread': '16', 'groupId': 'OG000'}]}]}, {'title': '2-Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.5', 'spread': '17.1', 'groupId': 'OG000'}]}]}, {'title': '5-Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.5', 'spread': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2-Years and 5-Years', 'description': 'The QuickDASH (Disabilities of the Arm, Shoulder, and Hand) score ranged from 0 (no disability) to 100 (most severe disability) based on 11 questions scored 1 to 5 each (for disability/symptoms) and 4 questions scored 1 to 5 each (for performance/sport/work). A lower score indicates a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data available at the time frame indicated'}, {'type': 'SECONDARY', 'title': 'Device Functionality: Constant Murley Score (CMS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PyroTITAN™ HRA Shoulder System', 'description': 'Participants implanted with PyroTITAN™ Humeral Resurfacing Arthroplasty (HRA) Shoulder System'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.7', 'spread': '15', 'groupId': 'OG000'}]}]}, {'title': '2-Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '79.9', 'spread': '10.3', 'groupId': 'OG000'}]}]}, {'title': '5-Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '83.7', 'spread': '10.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2-Years and 5-Years', 'description': 'The Constant Murley Score (CMS) is a 100-point scale composed of individual parameters. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and Range of Motion (ROM) (40 points). Subscales are combined to indicate a total CMS score. The total CMS score ranges from 0 to 100 points, with higher scores indicating a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data available at the time frame indicated'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PyroTITAN™ HRA Shoulder System', 'description': 'Participants implanted with PyroTITAN™ Humeral Resurfacing Arthroplasty (HRA) Shoulder System'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '137'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}]}], 'dropWithdraws': [{'type': 'Participant unwell & cannot travel', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Participant withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Revision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Participant did not return due to COVID-19 related lockdown', 'reasons': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'Participant failed to return for follow-up visits', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Participant relocation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were enrolled in the study at one (1) site in Australia and participated between 24 Oct 2016 to 08 Feb 2023.', 'preAssignmentDetails': 'Overall, 137 participants were enrolled in the study, and fifty-two (52) participants discontinued from the study before completion.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'PyroTITAN™ HRA Shoulder System', 'description': 'Participants implanted with PyroTITAN™ Humeral Resurfacing Arthroplasty (HRA) Shoulder System'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '57.0', 'spread': '12.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '100', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Australia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '137', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Dominant Side', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Right', 'measurements': [{'value': '123', 'groupId': 'BG000'}]}, {'title': 'Left', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '30.1', 'spread': '5.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Intention to Treat (ITT) population included all participants implanted with available data available.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-08-18', 'size': 738967, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-08-02T00:58', 'hasProtocol': True}, {'date': '2023-03-10', 'size': 710696, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-08-02T14:50', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 137}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-26', 'studyFirstSubmitDate': '2016-12-01', 'resultsFirstSubmitDate': '2024-08-26', 'studyFirstSubmitQcDate': '2016-12-01', 'lastUpdatePostDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-26', 'studyFirstPostDateStruct': {'date': '2016-12-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Device Survival: Kaplan-Meir Estimate', 'timeFrame': '2 years', 'description': 'Device survival was defined as the absence of device fracture at the two year time-point. Percentage of participants with survival of the device estimated using the Kaplan-Meier method.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Device-Related Adverse Events', 'timeFrame': 'Post-operatively to 5-Years', 'description': 'Count of participants with device-related Non-Serious \\& Serious Adverse Events were the event was related to device use (e.g., component breakage) as determined by investigator assessment.'}, {'measure': 'Cumulative Device Success', 'timeFrame': '2-Years and 5-Years', 'description': 'Device success was defined as the absence of device fracture over time. Cumulative device success was determined by the percentage of participants with no device fractures by the two year \\& five year time-points.'}, {'measure': 'Cumulative Device Survival', 'timeFrame': '2-Years and 5-Years', 'description': 'Device survival was defined as the absence of device revision over time. Cumulative device survival was determined by the percentage of participants with no device revisions by the two year \\& five year time-points.'}, {'measure': 'Device Functionality: American Shoulder and Elbow Surgeons (ASES) Score', 'timeFrame': 'Baseline, 2-Years and 5-Years', 'description': 'ASES scores range from 0 to 100, with a score of 0 indicating a worse shoulder condition and 100 indicating the best shoulder condition.'}, {'measure': 'Device Functionality: Visual Analog Scale (VAS) - Pain', 'timeFrame': 'Baseline, 2-Years and 5-Years', 'description': 'The VAS Pain score range was from 0 to 100, with 0 representing no pain and 100 representing the worse possible pain.'}, {'measure': 'Device Functionality: Visual Analog Scale (VAS) - Satisfaction', 'timeFrame': 'Baseline, 2-Years and 5-Years', 'description': 'The VAS Satisfaction score range was from 0 to 100, with 0 representing the worst result and 100 representing the best result.'}, {'measure': 'Device Functionality: Western Ontario Osteoarthritis Score (WOOS)', 'timeFrame': 'Baseline, 2-Years and 5-Years', 'description': 'The WOOS score was based on 19 questions ranging from 0 to 100 with 0 being the best result and 100 being the worst result. A lower score indicated a better outcome.'}, {'measure': 'Device Functionality: QuickDASH Outcome Measure', 'timeFrame': 'Baseline, 2-Years and 5-Years', 'description': 'The QuickDASH (Disabilities of the Arm, Shoulder, and Hand) score ranged from 0 (no disability) to 100 (most severe disability) based on 11 questions scored 1 to 5 each (for disability/symptoms) and 4 questions scored 1 to 5 each (for performance/sport/work). A lower score indicates a better outcome.'}, {'measure': 'Device Functionality: Constant Murley Score (CMS)', 'timeFrame': 'Baseline, 2-Years and 5-Years', 'description': 'The Constant Murley Score (CMS) is a 100-point scale composed of individual parameters. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and Range of Motion (ROM) (40 points). Subscales are combined to indicate a total CMS score. The total CMS score ranges from 0 to 100 points, with higher scores indicating a better outcome.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Arthritis']}, 'descriptionModule': {'briefSummary': 'The study is designed as a single center, post-market, non-randomized, open-label, observational clinical study with retrospective and prospective enrollment to evaluate the 2-year post implantation survivorship of the PyroTITAN™ HRA device following the implementation of a new proof test to identify and eliminate devices with sub-standard mechanical integrity.', 'detailedDescription': 'The study is designed as a single center, post-market, non-randomized, open-label, observational clinical study with retrospective and prospective enrollment to evaluate the 2-year post implantation survivorship of the PyroTITAN™ HRA device following the implementation of a new proof test to identify and eliminate devices with sub-standard mechanical integrity. The results will be compared to data collected in a prior study conducted before implementing the new proof test. The PyroTITAN™ HRA Shoulder prosthesis device configuration will include humeral resurfacing CAP without cement. Patients will be selected retrospectively and prospectively for recruitment into the study based upon the normally accepted criteria for primary shoulder resurfacing arthroplasty.\n\n137 subjects with PyroTITAN™ HRA Shoulder prosthesis arthroplasties will be implanted and followed for up to 60 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects who require humeral head resurfacing arthroplasty.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients of either sex will be included, if they:\n\n1. Present (prospective cohort) or presented (retrospective cohort) for primary shoulder surface replacement or arthroplasty with any of the following diagnoses:\n\n 1. Osteoarthritis\n 2. Rheumatoid / Inflammatory Arthritis\n 3. Post-traumatic arthritis.\n 4. Focal and large (Hill-Sachs) osteochondral defects.\n2. Subject receives (prospective cohort) the PyroTITAN HRA device after the re-release of the product or received (retrospective cohort) the PyroTITAN HRA device after the re- release of the product and is enrolled in the study prior to their two-year follow-up visit.\n3. Subject is able to or capable of providing consent to participate in the clinical investigation.\n4. Subject agrees to comply with this protocol, including participating in required follow-up visits at the investigations site and completing study questionnaires.\n5. Subject is at least 18 years of age and skeletally mature at the time of surgery.\n\nExclusion Criteria:\n\nPatients will be excluded from participation if they:\n\n1. Has/had destruction of the proximal humerus to preclude rigid fixation of the humeral component.\n2. Has/had insufficient bone quality as determined by intra- operative evaluation.\n3. Has/had arthritis with defective rotator cuff.\n4. Has/had had a failed rotator cuff surgery.\n5. Has/had loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.\n6. Has/had evidence of active infection.\n7. Present/presented with a condition of neuromuscular compromise of the shoulder (e.g., neuropathic joints or brachioplexus injury with a flail shoulder joint).\n8. Are unwilling or unable to comply with a rehabilitation program or would fail to return for the postoperative follow- up visits prescribed by the protocol.\n9. Are/were skeletally immature.\n10. Has/had a known allergic reaction to PyroCarbon.\n11. Has/had other conditions such as central nervous system disturbances, alcohol or drug addiction, etc. that may make effective evaluation of the joint replacement difficult or impossible.\n12. Has/had known, active metastatic or neoplastic disease.\n13. Are/were taking \\> 10mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to surgery.\n14. Are/were under 21 years of age or over 75.\n15. Require/required glenoid replacement.\n16. Retrospective patients cannot be enrolled if they are two year or greater out from the index surgery.\n17. Women, who are pregnant or are planning to become pregnant.'}, 'identificationModule': {'nctId': 'NCT02983292', 'acronym': 'HRA', 'briefTitle': 'PyroTITAN Humeral Resurfacing Arthroplasty (HRA)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Smith & Nephew, Inc.'}, 'officialTitle': 'A Clinical and Radiological Study to Evaluate the Safety and Efficacy of the PyroTITAN Humeral Resurfacing Arthroplasty (HRA) Device in a New Cohort of Patients After Product Re-Release', 'orgStudyIdInfo': {'id': 'T-HRA-003'}}, 'armsInterventionsModule': {'interventions': [{'name': 'PyroTITAN™ HRA', 'type': 'DEVICE', 'description': 'Humeral Resurfacing'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4001', 'city': 'Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'The Brisbane Hand and Upper Limb Research Institute', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}], 'overallOfficials': [{'name': 'Belinda Larson', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Smith & Nephew, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Smith & Nephew, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}