Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:53 PM
Study NCT ID:
NCT06394856
Status:
COMPLETED
Last Update Posted:
2024-06-13
First Post:
2024-04-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Outcomes of Rotator Cuff Repair With a Modified Versus Classic Double-Row Suture -Bridge Techniques
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': 89}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-12', 'studyFirstSubmitDate': '2024-04-21', 'studyFirstSubmitQcDate': '2024-04-28', 'lastUpdatePostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'retear rate', 'timeFrame': '3 years', 'description': 'retear rate'}], 'secondaryOutcomes': [{'measure': 'time', 'timeFrame': '3 years', 'description': 'duration of operation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rotator Cuff Tears']}, 'descriptionModule': {'briefSummary': 'rotator cuff tears are one of the most common shoulder issues , affecting 20.7% of the general population .', 'detailedDescription': 'accompanied by shoulder pain and dysfunction'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* full-thickness supraspinatus\n* degenerative tears\n* age range 40 :65\n\nExclusion Criteria:\n\n* subscapularis tear\n* small and massive tears\n* traumatic tears\n* partial -thickness tear\n* revisioin surgery\n* glenohumeral arthretic changes and shoulder instability'}, 'identificationModule': {'nctId': 'NCT06394856', 'briefTitle': 'Comparison of Outcomes of Rotator Cuff Repair With a Modified Versus Classic Double-Row Suture -Bridge Techniques', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Comparison of Outcomes of Rotator Cuff Repair With a Modified Versus Classic Double-Row Suture -Bridge Techniques', 'orgStudyIdInfo': {'id': 'Soh-Med-23-04-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'knotless group', 'description': 'rotator cuff repair with a modified knotless anchors', 'interventionNames': ['Procedure: Rotator Cuff Repair With a Modified Versus Classic Double-Row Suture -Bridge Techniques']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'knot-tying group', 'description': 'rotator cuff repair with classic knot-tying double-row suture bridge technique by classic anchors', 'interventionNames': ['Procedure: Rotator Cuff Repair With a Modified Versus Classic Double-Row Suture -Bridge Techniques']}], 'interventions': [{'name': 'Rotator Cuff Repair With a Modified Versus Classic Double-Row Suture -Bridge Techniques', 'type': 'PROCEDURE', 'description': 'rotator cuff tears with modified versus classic double row suture bridge', 'armGroupLabels': ['knot-tying group', 'knotless group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '82511', 'city': 'Sohag', 'country': 'Egypt', 'facility': 'university Hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'overallOfficials': [{'name': 'Hossam M azab, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Sohag University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor orthopedic department', 'investigatorFullName': 'Hossam Eldin Mohamed Ahmed ElAzab', 'investigatorAffiliation': 'Sohag University'}}}}