Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-31 @ 12:57 PM
Study NCT ID:
NCT01513434
Status:
COMPLETED
Last Update Posted:
2012-01-20
First Post:
2012-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Femoral Tunnel Position on Conventional MRI After Anterior Cruciate Ligament Reconstruction-Transtibial Technique Versus Transportal Technique
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-19', 'studyFirstSubmitDate': '2012-01-16', 'studyFirstSubmitQcDate': '2012-01-19', 'lastUpdatePostDateStruct': {'date': '2012-01-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lysholm score', 'timeFrame': 'at least two years after surgery', 'description': 'Lysholm score was superior in transportal technique to transtibial technique.'}, {'measure': 'Position of femoral tunnel aperture', 'timeFrame': 'within one week after surgery', 'description': 'The position of the femoral tunnel aperture with transportal technique was more posterior than that of transtibial technique.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Anterior Cruciate Ligament Rupture']}, 'descriptionModule': {'briefSummary': 'The position of the femoral tunnel in anterior cruciate ligament (ACL) reconstruction has been assessed on three dimensional CT (3D-CT) scan or in cadaveric study. However, these methods have some issues; 3D-CT scan has a concern on radiation exposure and cadaveric study is not easily available nor an in vivo test. The purpose of this study is to compare the position of the femoral tunnel aperture on conventional MRI and the outcomes after single bundle ACL reconstruction using free tendon Achilles allograft between transportal technique and transtibial technique in active young men.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of anterior cruciate ligament rupture\n\nExclusion Criteria:\n\n* female\n* over 45 years old\n* the subjects who had ACL reconstruction with graft other than Achilles allograft\n* the subjects who had concomitant other ligament injuries on the same knee needing surgical treatment\n* revision ACL reconstruction\n* double bundle ACL reconstruction\n* concomitant full thickness cartilage injury needing cartilage repairing surgery'}, 'identificationModule': {'nctId': 'NCT01513434', 'briefTitle': 'Femoral Tunnel Position on Conventional MRI After Anterior Cruciate Ligament Reconstruction-Transtibial Technique Versus Transportal Technique', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Police Hospital'}, 'orgStudyIdInfo': {'id': 'NPH2008-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'transtibial technique', 'description': 'In anterior cruciate ligament reconstruction, femoral tunnel was made via tibial tunnel.', 'interventionNames': ['Procedure: transtibial technique', 'Procedure: anterior cruciate ligament reconstruction']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Transportal technique', 'description': 'In anterior cruciate ligament reconstruction, femoral tunnel was made via anteromedial portal.', 'interventionNames': ['Procedure: Transportal technique', 'Procedure: anterior cruciate ligament reconstruction']}], 'interventions': [{'name': 'transtibial technique', 'type': 'PROCEDURE', 'description': 'Femoral tunnel was made via tibial tunnel in anterior cruciate ligament reconstruction.', 'armGroupLabels': ['transtibial technique']}, {'name': 'Transportal technique', 'type': 'PROCEDURE', 'otherNames': ['anteromedial portal technique'], 'description': 'Femoral tunnel was made via anteromedial portal in anterior cruciate ligament reconstruction.', 'armGroupLabels': ['Transportal technique']}, {'name': 'anterior cruciate ligament reconstruction', 'type': 'PROCEDURE', 'description': 'femoral and tibial tunneling graft fixation on the femoral side with endobutton and on the tibial side with post-tie and interference screw', 'armGroupLabels': ['Transportal technique', 'transtibial technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '138-708', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'National Police Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Police Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Jung Ho Noh', 'investigatorAffiliation': 'National Police Hospital'}}}}