Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
Study NCT ID:
NCT05341518
Status:
WITHDRAWN
Last Update Posted:
2024-03-15
First Post:
2022-04-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Subscapularis Repair During Reverse Total Shoulder Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Participating sites failed to secure funding and study was not feasible at one site.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-14', 'studyFirstSubmitDate': '2022-04-18', 'studyFirstSubmitQcDate': '2022-04-18', 'lastUpdatePostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The American Shoulder and Elbow Surgeons (ASES) Shoulder Score', 'timeFrame': 'up to 12 months post-surgery', 'description': 'Scored from 0 (worst shoulder condition) to 100 (best shoulder condition)'}], 'secondaryOutcomes': [{'measure': 'Internal Rotator (IR) Strength', 'timeFrame': 'up to 12 months post-surgery', 'description': 'IR at the side and supported IR at 90˚ scapation; percent of nonsurgical side'}, {'measure': 'PROMIS Bank v1.1 - Pain Interference', 'timeFrame': 'up to 12 months post-surgery', 'description': 'PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population (usually U.S. general population).'}, {'measure': 'Shoulder Range of Motion', 'timeFrame': 'up to 12 months post-surgery', 'description': 'shoulder extension, flexion, internal rotation, abduction, adduction; percent of nonsurgical side'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Shoulder Osteoarthritis', 'Arthropathy Shoulder']}, 'descriptionModule': {'briefSummary': 'This multi-site study involving Northwestern Medicine, Beaumont Health, and Loyola Medicine seeks to answer the following question: do patients who undergo subscapularis (SSc) repair during reverse total shoulder arthroplasty (RSA) have better post-operative outcomes than patients who do not undergo SSc repair during RSA? The investigators hypothesize that patients who do not undergo SSc repair during RSA have better post-operative outcomes than patients who undergo SSc repair during RSA. This study will address the controversy surrounding SSc repair during RSA via a multi-institutional randomized controlled trial that will compare clinical outcomes of patients who receive SSc repair during RSA to those who do not.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '88 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Primary RSA procedure with repairable (intact) SSc\n2. Operation will be performed by a participating surgeon using Zimmer Biomet Comprehensive Reverse Shoulder System implant\n3. Diagnosis with imaging of arthropathy with rotator cuff insufficiency\n4. Surgical approach: Deltopectoral\n5. Fluent English speakers/readers\n\nExclusion Criteria:\n\n1. Minor (\\<18 y/o)/vulnerable populations (pregnant women, prisoners, adults unable to consent)\n2. Revision surgery\n3. Oncologic surgery\n4. non-ZB CRSS implants\n5. Unrepairable SSc'}, 'identificationModule': {'nctId': 'NCT05341518', 'briefTitle': 'Subscapularis Repair During Reverse Total Shoulder Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Subscapularis Repair During Reverse Total Shoulder Arthroplasty: a Randomized Control Trial', 'orgStudyIdInfo': {'id': 'STU00215591'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Subscapularis repair', 'description': 'Patients will undergo standard of care reverse total shoulder arthroplasty with subscapularis repair', 'interventionNames': ['Procedure: Subscapularis repair']}, {'type': 'NO_INTERVENTION', 'label': 'No repair', 'description': 'Patients will undergo standard of care reverse total shoulder arthroplasty. The subscapularis will not be repaired.'}], 'interventions': [{'name': 'Subscapularis repair', 'type': 'PROCEDURE', 'description': 'To complete reverse total shoulder arthroplasty, the surgeon must cut through the subscapularis muscle. In this arm of the study, the muscle will be repaired, rather than left to heal itself.', 'armGroupLabels': ['Subscapularis repair']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60153', 'city': 'Maywood', 'state': 'Illinois', 'country': 'United States', 'facility': 'Loyola Medicine', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'Beaumont Health', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}], 'overallOfficials': [{'name': 'Guido Marra, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University Feinberg School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no participant data to share. No participants were enrolled.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Orthopaedic Surgery', 'investigatorFullName': 'Guido Marra', 'investigatorAffiliation': 'Northwestern University'}}}}