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

Not Applicable

• Conditions: Anterior Cruciate Ligament Injury
• Interventions: Procedure: knee flexion angle 2; Procedure: knee flexion angle 1

• Registration Number: NCT02111759
• Lead Sponsor: University of Toronto Orthopaedic Sports Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-27
• Study First Submitted QC: 2014-04-08
• Study First Posted: 2014-04-11
• Study Start: 2014-05
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-09
• Last Update Posted: 2016-11-10
• Primary Completion: 2018-02
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 204

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
knee flexion angle 2	knee flexion angle 2	30 degrees of knee flexion during ACL graft fixation
knee flexion angle 1	knee flexion angle 1	0 degrees of knee flexion during ACL graft fixation

Primary Outcome Measures

Name	Time	Method
Knee Injury and Osteoarthritis Outcome Score (KOOS)	24 months postoperatively

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Women's College Hospital; 🇨🇦 Toronto, Ontario, Canada