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

University of Toronto Orthopaedic Sports Medicine204 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

204

Conditions

Anterior Cruciate Ligament Injury

Interventions

knee flexion angle 1PROCEDURE

0 degrees of knee flexion during ACL graft fixation

knee flexion angle 2PROCEDURE

30 degrees of knee flexion during ACL graft fixation

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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.

Locations (1)

Women's College Hospital

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Knee Injury and Osteoarthritis Outcome Score (KOOS)

Time frame: 24 months postoperatively

Secondary Outcomes

KOOS scores

Time frame: 3, 6, and 12 months

Marx Activity Score (MAS)

Time frame: 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

Time frame: 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

Time frame: 3, 6, 12, and 24 months

Data from ClinicalTrials.gov

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