Anterior Cruciate Ligament Injury Clinical Trial
— FIRMOfficial title:
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
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.
Status | Active, not recruiting |
Enrollment | 204 |
Est. completion date | February 2018 |
Est. primary completion date | February 2018 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years and older |
Eligibility |
Inclusion Criteria: - Male and female patients older than 16 years old with an isolated anterior cruciate ligament injury as diagnosed by clinical examination and MRI - No pre-existing arthritis as defined by the Kellgren-Lawrence radiographic rating system - Patients treated with an initial period of rehabilitation to eliminate swelling, optimize quadriceps strength and restore range of motion - 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. Exclusion Criteria: - Acute ACL injuries that have not undergone an initial period of physical therapy in order to restore the aforementioned parameters - Associated grade III injury to the MCL (medial opening >10mm at 30 degrees of knee flexion or any medial opening in extension) - Presence of a PCL or posterolateral corner injury - Lack of informed consent. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Women's College Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University of Toronto Orthopaedic Sports Medicine | Arthroscopy Association of North America |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Knee Injury and Osteoarthritis Outcome Score (KOOS) | 24 months postoperatively | No | |
Secondary | KOOS scores | 3, 6, and 12 months | No | |
Secondary | Marx Activity Score (MAS) | 3, 6, 12, 24 months | No | |
Secondary | the degree of extension loss in the affected knee (vs. contralateral knee) | the degree of extension in the affected knee as measured by a goniometer | 3, 6, 12, and 24 months | No |
Secondary | Side to side differences in anterior-posterior (AP) stability | differences in anterior-posterior knee (in the affected knee vs. the contralateral knee) as measured by the KT1000 arthrometer | 3, 6, 12, and 24 months | No |
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