Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2025-12-25 @ 11:19 PM
Study NCT ID:
NCT07236593
Status:
COMPLETED
Last Update Posted:
2025-11-19
First Post:
2025-11-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Remnant Preservation and Tibial Tunnel Widening After ACL Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070598', 'term': 'Anterior Cruciate Ligament Injuries'}], 'ancestors': [{'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 190}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2024-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-15', 'studyFirstSubmitDate': '2025-11-15', 'studyFirstSubmitQcDate': '2025-11-15', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Tibial Tunnel Enlargement', 'timeFrame': '12 months postoperatively'}], 'secondaryOutcomes': [{'measure': 'Percentage of Tibial Tunnel Enlargement', 'timeFrame': '12 months'}, {'measure': 'Tibial Tunnel Positioning (X & Y coordinates)', 'timeFrame': '2 Weeks'}, {'measure': 'Femoral Tunnel Diameter Change', 'timeFrame': '12 months'}, {'measure': 'Femoral Tunnel Positioning (X & Y coordinates)', 'timeFrame': '2 Weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anterior Cruciate Ligament Injury']}, 'descriptionModule': {'briefSummary': 'Anterior Cruciate Ligament (ACL) reconstruction is one of the most commonly performed orthopedic procedures. Tibial tunnel widening is a recognized postoperative complication that may affect graft stability and long-term outcomes. Recent studies have suggested that preserving the ACL remnant may improve biological healing and reduce tunnel widening, but the evidence remains inconclusive.\n\nThis prospective randomized study aims to evaluate whether remnant (stump) preservation and suturing during ACL reconstruction can reduce the risk of tibial tunnel widening compared with the conventional stump-resection technique.\n\nA total of 190 patients with recent ACL tears (\\<6 months) were randomly assigned into two equal groups: Group A underwent arthroscopic ACL reconstruction with remnant suturing, while Group B underwent standard reconstruction with stump resection. All patients were followed for 12 months postoperatively with serial CT evaluations to assess tunnel diameters and positioning.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 45 years\n* Acute ACL injury (\\<6 months)\n* Medically fit for surgery\n\nExclusion Criteria:\n\n* Age \\<18 or \\>45 years\n* Old or chronic ACL injuries (\\>6 months)\n* Multi-ligamentous knee injuries\n* Failed previous ACL reconstruction\n* Associated mal-alignment deformities\n* Absence of identifiable ACL stump'}, 'identificationModule': {'nctId': 'NCT07236593', 'briefTitle': 'Remnant Preservation and Tibial Tunnel Widening After ACL Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Remnant Preservation in Anterior Cruciate Ligament Reconstruction: Does Stump Suturing Reduce the Risk of Tibial Tunnel Widening? A CT-Based Study', 'orgStudyIdInfo': {'id': 'N-473-2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stump-Suturing ACL Reconstruction', 'interventionNames': ['Procedure: Stump-Suturing ACL Reconstruction']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stump-Resection ACL Reconstruction', 'interventionNames': ['Procedure: Stump-Resection ACL Reconstruction']}], 'interventions': [{'name': 'Stump-Suturing ACL Reconstruction', 'type': 'PROCEDURE', 'description': 'Patients in this group undergo arthroscopic ACL reconstruction with preservation and suturing of the native ACL remnant (stump) around the graft. The technique aims to enhance graft revascularization and biological healing, potentially reducing tibial tunnel widening.', 'armGroupLabels': ['Stump-Suturing ACL Reconstruction']}, {'name': 'Stump-Resection ACL Reconstruction', 'type': 'PROCEDURE', 'description': 'Patients in this group undergo standard arthroscopic ACL reconstruction with complete resection of the ACL remnant (stump) prior to graft placement. This represents the conventional surgical approach for ACL reconstruction.', 'armGroupLabels': ['Stump-Resection ACL Reconstruction']}]}, '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'}}}}