Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-02-22 @ 9:04 AM
Study NCT ID:
NCT03021733
Status:
COMPLETED
Last Update Posted:
2017-09-18
First Post:
2017-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Cohort Study of Surgical and Non-surgical Management of Rotator Cuff Tears
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 222}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-15', 'studyFirstSubmitDate': '2017-01-12', 'studyFirstSubmitQcDate': '2017-01-13', 'lastUpdatePostDateStruct': {'date': '2017-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Veterans Rand VR-12 Quality of Life Score', 'timeFrame': 'baseline'}, {'measure': 'Veterans Rand VR-12 Quality of Life Score', 'timeFrame': '4 weeks'}, {'measure': 'Veterans Rand VR-12 Quality of Life Score', 'timeFrame': '8 weeks'}, {'measure': 'Veterans Rand VR-12 Quality of Life Score', 'timeFrame': '16 weeks'}, {'measure': 'Veterans Rand VR-12 Quality of Life Score', 'timeFrame': '32 weeks'}, {'measure': 'Veterans Rand VR-12 Quality of Life Score', 'timeFrame': '48 weeks'}, {'measure': 'Veterans Rand VR-12 Quality of Life Score', 'timeFrame': '64 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Full Thickness Rotator Cuff Tear']}, 'descriptionModule': {'briefSummary': 'This project will involve planning and implementing a two-arm prospective pragmatic cohort clinical trial in patients with known rotator cuff tears.', 'detailedDescription': 'This project will involve planning and implementing a two-arm prospective pragmatic cohort clinical trial in patients with known rotator cuff tears. Pragmatic or effectiveness clinical trials reflect real world settings and thus have greater external generalizability than efficacy trials. The evaluation component in this trial will be three-fold: first, the study team will compare the success of patients undergoing operative versus non-operative management and identify which variables predict success in each group; second, investigators will attempt to predict which patients end up choosing, along with their care giver(s), operative versus non-operative management by examining the predictive capability of a selection of variables; third, investigators will evaluate the clinical research site(s), personnel, and implementation processes for their capability to implement clinical trials with the intent of planning for a future large multi-site clinical trial building on the results of the present study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients presenting to an orthopaedic clinic with full-thickness rotator cuff tears as determined by surgeon opinion and imaging', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years of age with full-thickness rotator cuff tears eligible for operative repair\n\nExclusion Criteria:\n\n* less than 18 years old,\n* non-operative rotator cuff tears,\n* calcific tendonitis, fracture, adhesive capsulitis,\n* severe osteoarthritis of the shoulder,\n* no prior shoulder surgery'}, 'identificationModule': {'nctId': 'NCT03021733', 'briefTitle': 'A Pilot Cohort Study of Surgical and Non-surgical Management of Rotator Cuff Tears', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'A Pilot Cohort Study of Surgical and Non-surgical Management of Rotator Cuff Tears', 'orgStudyIdInfo': {'id': 'HUM00056320'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-operative', 'description': 'Patients whom elected non-operative treatment'}, {'label': 'Operative', 'description': 'Patients whom elected operative treatment', 'interventionNames': ['Procedure: Operative management']}], 'interventions': [{'name': 'Operative management', 'type': 'PROCEDURE', 'description': 'Rotator cuff surgery', 'armGroupLabels': ['Operative']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No individual patient data will be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Joel Gagnier', 'investigatorAffiliation': 'University of Michigan'}}}}