Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-25 @ 7:54 PM
Study NCT ID:
NCT01267435
Status:
COMPLETED
Last Update Posted:
2010-12-28
First Post:
2010-12-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Tibial and Femoral Tunnel Position After Arthroscopic Reconstruction of the Anterior Cruciate Ligament
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059549', 'term': 'Anterior Cruciate Ligament Reconstruction'}], 'ancestors': [{'id': 'D001178', 'term': 'Arthroplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-27', 'studyFirstSubmitDate': '2010-12-27', 'studyFirstSubmitQcDate': '2010-12-27', 'lastUpdatePostDateStruct': {'date': '2010-12-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of correct femoral tunnel position', 'timeFrame': '5 min after operation', 'description': 'we evalauted femoral tunnel positions'}], 'secondaryOutcomes': [{'measure': 'number of correct Tibial tunnel position', 'timeFrame': '5 min after operation', 'description': 'we evalauted tibial tunnel position'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Arthroscopy, Anterior Cruciate Ligament, Tibial Tunnel.'], 'conditions': ['Anterior Cruciate Ligament Rupture']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the accuracy of tunnel positions in anterior cruciate ligament reconstruction', 'detailedDescription': 'The tunnel placement in ACL reconstruction is the most important predictor of clinical outcome and there is a high rate of inaccurate tunnel placements, even when performed by experienced surgeons.Tibial and femoral tunnel positions are one of the major concerns in anterior cruciate ligament reconstruction which have a great impact on the final surgical results'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* anterior cruciate ligament rupturing\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT01267435', 'briefTitle': 'Evaluation of Tibial and Femoral Tunnel Position After Arthroscopic Reconstruction of the Anterior Cruciate Ligament', 'organization': {'class': 'OTHER', 'fullName': 'Isfahan University of Medical Sciences'}, 'officialTitle': 'Study of Evaluation of Tibial and Femoral Tunnel Position After ACL Reconstruction', 'orgStudyIdInfo': {'id': 'ASD-1213-8'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'determining correct tunnel positions', 'interventionNames': ['Procedure: Anterior cruciate ligament reconstruction']}], 'interventions': [{'name': 'Anterior cruciate ligament reconstruction', 'type': 'PROCEDURE', 'otherNames': ['ACL reconstruction'], 'description': 'reconstruct the anterior cruciate ligament rupturing', 'armGroupLabels': ['determining correct tunnel positions']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'state': 'Tehran Province', 'country': 'Iran', 'facility': 'Akhtar university hospital', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'hamidreza shemshaki, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'research comittee'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Isfahan University of Medical Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shahid Beheshti University of Medical Sciences', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Dr. Alireza Yousefy/Associate Professor of Medical Education', 'oldOrganization': 'Shaheed Beheshty University of Medical Sciences'}}}}