Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2025-12-25 @ 12:45 PM
Study NCT ID:
NCT01025895
Status:
UNKNOWN
Last Update Posted:
2009-12-04
First Post:
2009-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anterior Cruciate Ligament (ACL) Reconstruction: Single Bundle Versus Double Bundle
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2013-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-12-03', 'studyFirstSubmitDate': '2009-12-03', 'studyFirstSubmitQcDate': '2009-12-03', 'lastUpdatePostDateStruct': {'date': '2009-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'WOMAC, VAS, SF-36, Lisholm, Knee society score, isokinetic muscle strength testing, Single HOP test , Tripple Hop Test', 'timeFrame': 'pre-op. 1 day post op., 7-14 days post op., 6 weeks post op., 12 weeks post op., 26 weeks post op., 1 year post op., 2 years post op.'}]}, 'conditionsModule': {'keywords': ['arthroscopic surgical procedure'], 'conditions': ['Anterior Cruciate Ligament Tear']}, 'descriptionModule': {'briefSummary': 'ACL tear is a common injury among athletes. The recommended treatment includes reconstruction of the ligament. The common reconstruction technique is single bundle reconstruction. However, this technique does not simulate the natural structure of the ligament. The purpose of the study is to compare between the common procedure, Single Bundle reconstruction with the Double Bundle reconstruction technique.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* knee instability with a history of ACL tear\n* diagnosed ACL tear according to MRI\n* age range 16-40.\n\nExclusion Criteria:\n\n* previous surgery in the knees\n* multiple ligament raptures\n* partial ACL tear\n* severe cartilage degeneration\n* genovaruse/genovalgus\n* thin hamstrings tendons\n* oper epiphysis in the knee joint\n* patient with muscle/neurological problem that increases the tendency to fall'}, 'identificationModule': {'nctId': 'NCT01025895', 'briefTitle': 'Anterior Cruciate Ligament (ACL) Reconstruction: Single Bundle Versus Double Bundle', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Assaf-Harofeh Medical Center'}, 'orgStudyIdInfo': {'id': '144/09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'single bundle', 'description': 'acl reconstruction - single bundle technique', 'interventionNames': ['Procedure: acle reconstruction - single bundle technique']}, {'type': 'EXPERIMENTAL', 'label': 'double bundle', 'description': 'acl reconstruction - double bundle technique', 'interventionNames': ['Procedure: acl reconstruction - double bundle technique']}], 'interventions': [{'name': 'acl reconstruction - double bundle technique', 'type': 'PROCEDURE', 'armGroupLabels': ['double bundle']}, {'name': 'acle reconstruction - single bundle technique', 'type': 'PROCEDURE', 'armGroupLabels': ['single bundle']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assaf-Harofeh Medical Center', 'class': 'OTHER_GOV'}}}}