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

University of Toronto Orthopaedic Sports Medicine

Status

Unknown

Conditions

Anterior Cruciate Ligament Injury

Treatments

Procedure: knee flexion angle 2

Procedure: knee flexion angle 1

Study type

Interventional

Funder types

Other

Identifiers

NCT02111759

UTOSM0001

Details and patient eligibility

About

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.

Enrollment

204 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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.