Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-02-22 @ 4:43 AM
Study NCT ID:
NCT02111759
Status:
UNKNOWN
Last Update Posted:
2016-11-10
First Post:
2014-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Knee Flexion Angle for Graft Fixation During Single-Bundle Anterior Cruciate Ligament 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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 204}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2018-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-11-09', 'studyFirstSubmitDate': '2014-03-27', 'studyFirstSubmitQcDate': '2014-04-08', 'lastUpdatePostDateStruct': {'date': '2016-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knee Injury and Osteoarthritis Outcome Score (KOOS)', 'timeFrame': '24 months postoperatively'}], 'secondaryOutcomes': [{'measure': 'KOOS scores', 'timeFrame': '3, 6, and 12 months'}, {'measure': 'Marx Activity Score (MAS)', 'timeFrame': '3, 6, 12, 24 months'}, {'measure': 'the degree of extension loss in the affected knee (vs. contralateral knee)', 'timeFrame': '3, 6, 12, and 24 months', 'description': 'the degree of extension in the affected knee as measured by a goniometer'}, {'measure': 'Side to side differences in anterior-posterior (AP) stability', 'timeFrame': '3, 6, 12, and 24 months', 'description': 'differences in anterior-posterior knee (in the affected knee vs. the contralateral knee) as measured by the KT1000 arthrometer'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Anterior Cruciate Ligament Injury']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to conduct a randomized controlled trial to determine if the knee flexion angle (KFA) during anterior cruciate ligament reconstruction (ACLR) graft fixation has an effect on postoperative outcomes. The specific research questions are: what is the effect of the KFA on 1) patient-reported outcomes; 2) postoperative extension loss; 3) antero-posterior (AP) knee stability; 4) rate of re-operation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients older than 16 years old with an isolated anterior cruciate ligament injury as diagnosed by clinical examination and MRI\n* No pre-existing arthritis as defined by the Kellgren-Lawrence radiographic rating system\n* Patients treated with an initial period of rehabilitation to eliminate swelling, optimize quadriceps strength and restore range of motion\n* surgical management with a transtibial or anteromedial portal single-bundle ACLR with bone patella tendon bone (BPTB) autograft by a fellowship-trained sports medicine surgeon.\n\nExclusion Criteria:\n\n* Acute ACL injuries that have not undergone an initial period of physical therapy in order to restore the aforementioned parameters\n* Associated grade III injury to the MCL (medial opening \\>10mm at 30 degrees of knee flexion or any medial opening in extension)\n* Presence of a PCL or posterolateral corner injury\n* Lack of informed consent.'}, 'identificationModule': {'nctId': 'NCT02111759', 'acronym': 'FIRM', 'briefTitle': 'The Effect of Knee Flexion Angle for Graft Fixation During Single-Bundle Anterior Cruciate Ligament Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'University of Toronto Orthopaedic Sports Medicine'}, 'officialTitle': 'The Effect of Knee Flexion Angle for Graft Fixation During Single-Bundle Anterior Cruciate Ligament Reconstruction - A Multicentre, Patient and Assessor Blinded, Stratified, Two-arm Parallel Group Superiority Trial', 'orgStudyIdInfo': {'id': 'UTOSM0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'knee flexion angle 2', 'description': '30 degrees of knee flexion during ACL graft fixation', 'interventionNames': ['Procedure: knee flexion angle 2']}, {'type': 'OTHER', 'label': 'knee flexion angle 1', 'description': '0 degrees of knee flexion during ACL graft fixation', 'interventionNames': ['Procedure: knee flexion angle 1']}], 'interventions': [{'name': 'knee flexion angle 1', 'type': 'PROCEDURE', 'description': '0 degrees of knee flexion during ACL graft fixation', 'armGroupLabels': ['knee flexion angle 1']}, {'name': 'knee flexion angle 2', 'type': 'PROCEDURE', 'description': '30 degrees of knee flexion during ACL graft fixation', 'armGroupLabels': ['knee flexion angle 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5S1B1', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "Women's College Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Jaskarndip Chahal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Toronto Orthopaedic Sports Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Toronto Orthopaedic Sports Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Arthroscopy Association of North America', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jaskarndip Chahal', 'investigatorAffiliation': 'University of Toronto Orthopaedic Sports Medicine'}}}}