The Effect of Knee Flexion Angle for Graft Fixation During Single-Bundle Anterior Cruciate Ligament Reconstruction

Study Overview
=================
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.

Official 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

Conditions
-----------------
Anterior Cruciate Ligament Injury

Intervention / Treatment
-----------------
* Procedure: knee flexion angle 1
* Procedure: knee flexion angle 2


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: knee flexion angle 2<br>30 degrees of knee flexion during ACL graft fixation | Procedure: knee flexion angle 2<br>* 30 degrees of knee flexion during ACL graft fixation<br>|
| Other: knee flexion angle 1<br>0 degrees of knee flexion during ACL graft fixation | Procedure: knee flexion angle 1<br>* 0 degrees of knee flexion during ACL graft fixation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) |  | 24 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | the degree of extension in the affected knee as measured by a goniometer | 3, 6, 12, and 24 months | 
| 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 |