Anterior Cruciate Ligament Injury
Conditions
Brief summary
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.
Interventions
PROCEDUREknee flexion angle 1
0 degrees of knee flexion during ACL graft fixation
PROCEDUREknee flexion angle 2
30 degrees of knee flexion during ACL graft fixation
Sponsors
Arthroscopy Association of North America
University of Toronto Orthopaedic Sports Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | 24 months postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| KOOS scores | 3, 6, and 12 months | — |
| Marx Activity Score (MAS) | 3, 6, 12, 24 months | — |
| the degree of extension loss in the affected knee (vs. contralateral knee) | 3, 6, 12, and 24 months | the degree of extension in the affected knee as measured by a goniometer |
| Side to side differences in anterior-posterior (AP) stability | 3, 6, 12, and 24 months | differences in anterior-posterior knee (in the affected knee vs. the contralateral knee) as measured by the KT1000 arthrometer |
Countries
Canada
Outcome results
None listed