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

University of Toronto Orthopaedic Sports Medicine1 site in 1 country204 target enrollmentMay 2014

ConditionsAnterior Cruciate Ligament Injury

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Anterior Cruciate Ligament Injury
Sponsor: University of Toronto Orthopaedic Sports Medicine
Enrollment: 204
Locations: 1
Primary Endpoint: Knee Injury and Osteoarthritis Outcome Score (KOOS)
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

May 2014

End Date

February 2018

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Toronto Orthopaedic Sports Medicine

Responsible Party

Principal Investigator

Jaskarndip Chahal

Principal Investigator

University of Toronto Orthopaedic Sports Medicine

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.

Outcomes

Primary Outcomes

Knee Injury and Osteoarthritis Outcome Score (KOOS)

Time Frame: 24 months postoperatively

Secondary Outcomes

Side to side differences in anterior-posterior (AP) stability(3, 6, 12, and 24 months)
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)