Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-30 @ 9:14 PM
Study NCT ID:
NCT04188704
Status:
COMPLETED
Last Update Posted:
2019-12-06
First Post:
2019-11-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study of the Inclination Angle and Complications of Eccentric Grafts Position in ACL Reconstruction and Normal ACL: Retrospective Cohort
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-04', 'studyFirstSubmitDate': '2019-11-30', 'studyFirstSubmitQcDate': '2019-12-04', 'lastUpdatePostDateStruct': {'date': '2019-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inclination angle', 'timeFrame': '6 months', 'description': 'Mean anterior cruciate ligament inclination angle in sagital x-ray (degree)'}], 'secondaryOutcomes': [{'measure': 'post-operative complications', 'timeFrame': '6 months', 'description': 'number of participants with revision, infection, reflex sympathetic dystrophy and re-rupture'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ACL', 'screw fixation', 'graft inclination', 'reconstruction'], 'conditions': ['Anterior Cruciate Ligament Injuries']}, 'descriptionModule': {'briefSummary': 'The anatomic ACL reconstruction aims at functional restoration of the ACL to its native dimensions, collagen orientation and insertion sites. Even if the anatomic foot prints are correctly chosen for the tibial and femoral tunnels does the position of interference screw in the tibial tunnel alter the ACL orientation? The study hypothesized that the position of interference screw in the tibial tunnel would alter the graft orientation in anatomic ACL reconstruction. The purpose of this study was to compare graft orientation and inclination angle with posterolateral and anteromedial interference screw position in tibial tunnel in aperture fixation techniques.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* magnetic resonance imaging (MRI) of patients with ACL reconstruction was compared to MRI in which ACL was intact.\n* patients with isolated ACL injury who underwent ACL reconstruction surgery using quadripled hamstrings graft and operated by a single senior surgeon\n* Both pre-operative and post-operative MRI should be available for assessment\n* No history of trauma in the post-operative or rehabilitation period\n\nExclusion Criteria:\n\n* Concomitant bony or other ligament injury to the same knee\n* history of previous surgery to the same knee\n* Revision ACL reconstruction surgery\n* surgery done at other center or by other doctors at our institute\n* Pre-operative and/or post-operative MRI not available'}, 'identificationModule': {'nctId': 'NCT04188704', 'briefTitle': 'Comparative Study of the Inclination Angle and Complications of Eccentric Grafts Position in ACL Reconstruction and Normal ACL: Retrospective Cohort', 'organization': {'class': 'OTHER', 'fullName': 'Ramathibodi Hospital'}, 'officialTitle': 'Comparative Study of the Inclination Angle and Complications of Eccentric Grafts Position in ACL Reconstruction and Normal ACL: Retrospective Cohort', 'orgStudyIdInfo': {'id': 'MTU-EC-OT-1-182/60'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Anterior cruciate ligament normal', 'description': 'normal Anterior cruciate ligament reconstruction', 'interventionNames': ['Procedure: Interference screw']}, {'type': 'EXPERIMENTAL', 'label': 'Anterior cruciate ligament reconstruction', 'description': 'Anterior cruciate ligament reconstruction and Position screw fixation', 'interventionNames': ['Procedure: Interference screw']}], 'interventions': [{'name': 'Interference screw', 'type': 'PROCEDURE', 'description': 'Anterior cruciate ligament reconstruction (anterior screw fixation or posterior screw fixation)', 'armGroupLabels': ['Anterior cruciate ligament normal', 'Anterior cruciate ligament reconstruction']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ramathibodi Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Thammasat University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principle investigator', 'investigatorFullName': 'Jatupon Kongtharvonskul', 'investigatorAffiliation': 'Ramathibodi Hospital'}}}}