Ignite Creation Date:
2025-12-26 @ 5:21 PM
Ignite Modification Date:
2025-12-29 @ 5:01 AM
Study NCT ID:
NCT04588506
Status:
TERMINATED
Last Update Posted:
2025-06-26
First Post:
2020-10-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tendon Transfer Rotator Cuff Tear
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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'Lack of enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-20', 'studyFirstSubmitDate': '2020-10-08', 'studyFirstSubmitQcDate': '2020-10-08', 'lastUpdatePostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '12-point difference in American Shoulder and Elbow Surgeon (ASES) scores', 'timeFrame': 'At one year post-operative follow-up visit', 'description': 'The American Shoulder and Elbow Surgeon (ASES) score is a validated and reliable outcomes measure in patients with a wide variety of shoulder disorders. The ASES questionnaire examines two domains- pain (50 points) and function (50 points)- in a self-reported questionnaire and is scored on a 100-point scale. The minimum score is zero and the maximum is 100. A higher score means better outcome.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Massive Rotator Cuff Tears', 'Tendon Transfer', 'Rotator Cuff Tears', 'Tendon Transfer Techniques'], 'conditions': ['Rotator Cuff Tears']}, 'descriptionModule': {'briefSummary': 'This is a prospective randomized study on using muscle tendons to repair tears of the muscles on the shoulder. There are 3 muscles covering the shoulder joint- supraspinatus, infraspinatus and subscapularis. Large tears involving these muscles can be treated by using some muscle from another location of the body known as Tendon transfer techniques. These muscle tendons may be from the lower back (Latissimus Dorsi), upper pack (lower trapezius) or chest (pectoralis). There are currently no studies to show which tendon transfer technique has better outcomes.\n\nThis study comprises two trials and a total of 84 participants would be enrolled. Each trial comparing the patient reported outcomes between two tendon transfer techniques. Large tears involving the supraspinatus and infraspinatus would be repaired using either the Latissimus dorsi technique or Lower trapezius technique. 21 patients would be randomly assigned to either groups. The second trial would be comparing the Latissimus dorsi technique and pectoralis technique in large tears of the subscapularis muscle. Another 21 patients would be randomly assigned to either groups.\n\nThe investigators are studying to see if the Lower Trapezius and Pectoralis transfer techniques for muscle tear repairs would have better post-surgical outcomes compared with Latissimus Dorsi transfer technique.\n\nFor both trials, participants would be followed up for 2 years and post-surgical outcomes would be compared between treatment groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must have massive, irreparable tear of the posterior-superior rotator cuff\n* Subjects between 18 years and 65 years (≥ 18 and ≤ 65 years of age).\n* Diagnosis of no to minimal glenohumeral arthritis- Hamada 1 and 2\n* Subject with irreparable subscapularis tendon tear (Arms 3 and 4 ONLY)\n\nExclusion Criteria:\n\n* Subjects having severe glenohumeral arthritis\n* History of prior tendon transfer\n* Axillary nerve injury\n* Deltoid deficiency\n* Subjects with pseudo paralysis\n* History of post-operative deep shoulder infection\n* Non-English-speaking subjects.\n* Subject has any condition, that in the opinion of the investigator, would prevent them from completing this study\n* Subject with irreparable subscapularis tendon tear (Arms 1 and 2 ONLY)'}, 'identificationModule': {'nctId': 'NCT04588506', 'briefTitle': 'Tendon Transfer Rotator Cuff Tear', 'organization': {'class': 'OTHER', 'fullName': 'University of Maryland, Baltimore'}, 'officialTitle': 'Tendon Transfer Techniques for Massive Rotator Cuff Tear Repairs: An Integrated Prospective Randomized Multicenter Trial', 'orgStudyIdInfo': {'id': 'HP-00091132'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cuff tear without subscapularis tear-Lower Trapezius group', 'description': 'Rotator cuff tears excluding the subscapularis muscle repaired using Lower Trapezius tendon', 'interventionNames': ['Procedure: Lower Trapezius Tendon Transfer Technique']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cuff tear without subscapularis tear-Latissimus Dorsi group', 'description': 'Rotator cuff tears excluding the subscapularis muscle repaired using Latissimus Dorsi tendon', 'interventionNames': ['Procedure: Latissimus Dorsi Tendon Transfer Technique']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cuff tear involving subscapularis tear-Pectoralis group', 'description': 'Rotator cuff tears involving the subscapularis muscle repaired using Pectoralis tendon', 'interventionNames': ['Procedure: Pectoralis Tendon Transfer Technique']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cuff tear involving subscapularis tear-Latissimus Dorsi group', 'description': 'Rotator cuff tears involving the subscapularis muscle repaired using Latissimus Dorsi tendon', 'interventionNames': ['Procedure: Latissimus Dorsi Tendon Transfer Technique']}], 'interventions': [{'name': 'Lower Trapezius Tendon Transfer Technique', 'type': 'PROCEDURE', 'description': 'Lower Trapezius tendon used in repairing cuff tear', 'armGroupLabels': ['Cuff tear without subscapularis tear-Lower Trapezius group']}, {'name': 'Latissimus Dorsi Tendon Transfer Technique', 'type': 'PROCEDURE', 'description': 'Latissimus Dorsi tendon used in repairing cuff tear', 'armGroupLabels': ['Cuff tear involving subscapularis tear-Latissimus Dorsi group', 'Cuff tear without subscapularis tear-Latissimus Dorsi group']}, {'name': 'Pectoralis Tendon Transfer Technique', 'type': 'PROCEDURE', 'description': 'Pectoralis tendon used in repairing cuff tear', 'armGroupLabels': ['Cuff tear involving subscapularis tear-Pectoralis group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'U of Maryland Baltimore', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Ashfaq S Hasan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'U of Maryland Baltimore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No individual participant data will be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Maryland, Baltimore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Ashfaq Hasan', 'investigatorAffiliation': 'University of Maryland, Baltimore'}}}}