Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-01-04 @ 3:32 AM
Study NCT ID:
NCT07289659
Status:
COMPLETED
Last Update Posted:
2025-12-17
First Post:
2025-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Arthroscopic Repair of Partial Thickness Articular-Side Rotator Cuff Tears: Transtendon Versus Conversion Repair Techniques
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2025-11-15', 'studyFirstSubmitQcDate': '2025-12-15', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'American Shoulder and Elbow Surgeons (ASES) Score', 'timeFrame': 'Baseline and 24 months postoperatively'}, {'measure': 'Constant-Murley Score (CMS)', 'timeFrame': 'Baseline and 24 months postoperatively'}, {'measure': 'Visual Analogue Scale (VAS) for Pain', 'timeFrame': 'Baseline and 24 months postoperatively'}], 'secondaryOutcomes': [{'measure': 'Range of Motion (ROM)', 'timeFrame': 'Preoperative and 24 months postoperatively.', 'description': 'Measure the range of:\n\n1. Forward flexion\n2. Abduction\n3. External rotation\n4. Internal rotation'}, {'measure': 'Complication Rate', 'timeFrame': 'Up to 24 months postoperatively', 'description': 'Number of cases with:\n\nStiffness Persistent pain Infection'}, {'measure': 'MRI Healing Status', 'timeFrame': '12 months postoperatively', 'description': 'Number of cases with complete healing in MRI'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Partial Thickness Articular-Side Rotator Cuff Tears']}, 'descriptionModule': {'briefSummary': 'This prospective randomized clinical trial compared two arthroscopic techniques for repairing partial-thickness articular-side rotator cuff tears: transtendon repair and conversion repair. Eligible patients with symptomatic tears exceeding 50% of tendon thickness, confirmed by MRI and intraoperative assessment, were randomly assigned to either repair technique. Functional outcomes, range of motion, complications, and MRI healing were assessed up to 24 months postoperatively'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients suffering symptomatic PT-RCTs exceeding 50% of the tendon thickness, documented by preoperative magnetic resonance imaging (MRI) and confirmed by arthroscopy intraoperative.\n* Failure of nonoperative management for at least 3 months.\n\nExclusion Criteria:\n\n* Prior shoulder surgery.\n* Severe concomitant pathologies including glenohumeral arthritis, advanced subscapularis tear, and biceps tendon rupture.\n* Associated Bankart lesion.\n* Patients with uncontrolled Diabetes mellites.'}, 'identificationModule': {'nctId': 'NCT07289659', 'briefTitle': 'Arthroscopic Repair of Partial Thickness Articular-Side Rotator Cuff Tears: Transtendon Versus Conversion Repair Techniques', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Arthroscopic Repair of Partial Thickness Articular Side Rotator Cuff Tears Using Transtendon Versus Conversion Repair Techniques.', 'orgStudyIdInfo': {'id': 'N-383-2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conversion Repair', 'description': 'Patients with PT-RCTs treated using the arthroscopic conversion technique.', 'interventionNames': ['Procedure: Arthroscopic Conversion Repair']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Transtendon Repair', 'description': 'Patients with PT-RCTs treated using the arthroscopic transtendon repair technique.', 'interventionNames': ['Procedure: Arthroscopic Transtendon Repair']}], 'interventions': [{'name': 'Arthroscopic Conversion Repair', 'type': 'PROCEDURE', 'description': 'Patients undergo arthroscopic conversion repair, where the partial-thickness tear is converted to a full-thickness tear and repaired using standard arthroscopic techniques.', 'armGroupLabels': ['Conversion Repair']}, {'name': 'Arthroscopic Transtendon Repair', 'type': 'PROCEDURE', 'description': 'Patients undergo arthroscopic transtendon repair, preserving the intact bursal surface of the tendon while repairing the articular-side defect using suture anchors.', 'armGroupLabels': ['Transtendon Repair']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Kasr Alainy', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Orthopedic surgery', 'investigatorFullName': 'Mahmoud Ahmed El-Desouky', 'investigatorAffiliation': 'Cairo University'}}}}