Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2025-12-30 @ 9:08 AM
Study NCT ID:
NCT04965103
Status:
COMPLETED
Last Update Posted:
2021-07-16
First Post:
2021-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Superior Capsule vs Bridging Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070636', 'term': 'Rotator Cuff Injuries'}], 'ancestors': [{'id': 'D012421', 'term': 'Rupture'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participant and research assistant collecting outcomes were blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-06', 'studyFirstSubmitDate': '2021-06-21', 'studyFirstSubmitQcDate': '2021-07-06', 'lastUpdatePostDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'American Shoulder and Elbow Surgeon Outcome - patient portion', 'timeFrame': '24 months', 'description': 'American Shoulder and Elbow Surgeon Outcome - patient portion (minimum score = 0, maximum score = 100, best outcome = 100)'}, {'measure': 'American Shoulder and Elbow Surgeon Outcome - patient portion', 'timeFrame': '12 months', 'description': 'American Shoulder and Elbow Surgeon Outcome - patient portion (minimum score = 0, maximum score = 100, best outcome = 100)'}, {'measure': 'American Shoulder and Elbow Surgeon Outcome - patient portion', 'timeFrame': '6 months', 'description': 'American Shoulder and Elbow Surgeon Outcome - patient portion (minimum score = 0, maximum score = 100, best outcome = 100)'}, {'measure': 'American Shoulder and Elbow Surgeon Outcome - patient portion', 'timeFrame': '3 months', 'description': 'American Shoulder and Elbow Surgeon Outcome - patient portion (minimum score = 0, maximum score = 100, best outcome = 100)'}], 'secondaryOutcomes': [{'measure': 'Western Ontario Rotator Cuff Index', 'timeFrame': '24 months', 'description': 'Western Ontario Rotator Cuff Index (score converted to /100, minimum = 0, maximum = 100, best outcome = 100)'}, {'measure': 'Western Ontario Rotator Cuff Index', 'timeFrame': '12 months', 'description': 'Western Ontario Rotator Cuff Index (score converted to /100, minimum = 0, maximum = 100, best outcome = 100)'}, {'measure': 'Western Ontario Rotator Cuff Index', 'timeFrame': '6 months', 'description': 'Western Ontario Rotator Cuff Index (score converted to /100, minimum = 0, maximum = 100, best outcome = 100)'}, {'measure': 'Western Ontario Rotator Cuff Index', 'timeFrame': '3 months', 'description': 'Western Ontario Rotator Cuff Index (score converted to /100, minimum = 0, maximum = 100, best outcome = 100)'}, {'measure': 'Disabilities of the Arm, Shoulder and Hand - QuickDASH', 'timeFrame': '24 months', 'description': 'Disabilities of the Arm, Shoulder and Hand - QuickDASH (minimum = 100, maximum = 0, best outcome = 0)'}, {'measure': 'Disabilities of the Arm, Shoulder and Hand - QuickDASH', 'timeFrame': '12 months', 'description': 'Disabilities of the Arm, Shoulder and Hand - QuickDASH (minimum = 100, maximum = 0, best outcome = 0)'}, {'measure': 'Disabilities of the Arm, Shoulder and Hand - QuickDASH', 'timeFrame': '6 months', 'description': 'Disabilities of the Arm, Shoulder and Hand - QuickDASH (minimum = 100, maximum = 0, best outcome = 0)'}, {'measure': 'Disabilities of the Arm, Shoulder and Hand - QuickDASH', 'timeFrame': '3 months', 'description': 'Disabilities of the Arm, Shoulder and Hand - QuickDASH (minimum = 100, maximum = 0, best outcome = 0)'}, {'measure': 'Tendon healing, assessed via MRI', 'timeFrame': '12 months', 'description': 'Tendon healing (classifications: intact or retorn)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['irreparable'], 'conditions': ['Rotator Cuff Tears']}, 'descriptionModule': {'briefSummary': 'Randomized controlled trial examining superior capsule reconstruction versus tendon repair with graft interposition in "irreparable" rotator cuff tears.', 'detailedDescription': 'RCT n = 50\n\nGroups:\n\n1. bridging\n2. SCR\n\nOutcomes:\n\n1. WORC\n2. ASES\n3. QuickDASH\n4. MRI at 12 months post-op'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Large to massive rotator cuff tear (with or without subscapularis tear) that may possibly be irreparable without the use of graft materials (confirmed intra-operatively)\n2. Either primary tear or re-tear after previous repair\n3. Radiographic evidence of Hamada stage 1-3, with or without Samilson \\& Prieto mild osteoarthritis (\\<3mm inferior osteophyte)\n\nExclusion Criteria:\n\n1. Primary glenohumeral osteoarthritis: radiographic evidence of Samilson \\& Prieto classification moderate or greater\n2. Cuff tear arthropathy (CTA): radiographic evidence of Hamada stage 4 or above\n3. Inflammatory joint disease of the shoulder (e.g. rheumatoid arthritis)\n4. Medical issues precluding surgery\n5. Unwilling or unable to complete study outcomes\n6. Worker's Compensation Claim or litigation"}, 'identificationModule': {'nctId': 'NCT04965103', 'acronym': 'SCR', 'briefTitle': 'Superior Capsule vs Bridging Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'Graft Reconstruction for Irreparable Rotator Cuff Tears: Superior Capsule Reconstruction or Tendon Repair With Graft Interposition', 'orgStudyIdInfo': {'id': 'REB15-1787'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bridging', 'description': 'Tendon repair with graft interposition', 'interventionNames': ['Procedure: Bridging']}, {'type': 'EXPERIMENTAL', 'label': 'SCR', 'description': 'Superior Capsule reconstruction', 'interventionNames': ['Procedure: SCR']}], 'interventions': [{'name': 'SCR', 'type': 'PROCEDURE', 'description': 'Superior Capsule reconstruction', 'armGroupLabels': ['SCR']}, {'name': 'Bridging', 'type': 'PROCEDURE', 'description': 'Tendon repair with graft interposition', 'armGroupLabels': ['Bridging']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ian Lo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Calgary'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan to share individual participant data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'collaborators': [{'name': "Worker's Compensation Board of Alberta (funding)", 'class': 'UNKNOWN'}, {'name': 'Canadian Orthopaedic Foundation (funding)', 'class': 'UNKNOWN'}, {'name': 'Arthroscopy Association of North America (funding)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}