NCT02018354

Standard ACL Reconstruction vs ACL + Lateral Extra-Articular Tenodesis Study

Multicenter Randomized Clinical Trial Comparing Anterior Cruciate Ligament Reconstruction With and Without Lateral Extra-articular Tenodesis in Individuals Who Are At High Risk of Graft Failure.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 624 (actual)
• Sponsor: University of Western Ontario, Canada · Academic / Other
• Sex: All
• Age: 14 Years – 25 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare outcomes (failure, function, strength, range of motion and quality of life) between patients who receive the usual anterior cruciate ligament (ACL) reconstructive surgery and patients who receive anterior cruciate ligament reconstructive surgery with a lateral extra-articular tenodesis (extra tendon repair on the outside of the knee). Some studies have shown high graft failure rates (ACL re-tear) in young individuals who return to pivoting contact sports following ACL reconstruction. This study is designed to look at whether or not adding this extra tendon repair reduces the risk of graft failure in this population.

Detailed description

This study is a pragmatic study for a parallel groups, randomized clinical trial in which 600 patients with anterior cruciate ligament insufficiency who are undergoing surgery, are randomly allocated to either ACL reconstruction alone (control) or ACL reconstruction with lateral extra-articular tenodesis (experimental). Surgeons, data collectors, and the data analyst will be blind to group allocation. The primary outcome is rate of failure. Secondary outcomes include disease specific quality of life, return to function and sport. Patients are followed for two years postoperative.

Conditions

• Anterior Cruciate Ligament Reconstruction

Interventions

Type	Name	Description
PROCEDURE	Lateral Extra-Articular Tenodesis (LET)	Lateral extra-articular tenodesis: A 1cm wide x 8cm long strip of iliotibial band is fashioned, leaving the Gerdys tubercle attachment intact. The graft is tunneled under the fibular collateral ligament (FCL) and attached to the femur with a Richards' staple (Smith \& Nephew), just distal to the intermuscular septum, proximal to the femoral insertion of the FCL. Fixation is performed with the knee at 70 degrees flexion, neutral rotation. Minimal tension is applied to the graft. The free end is then looped back onto itself and sutured using the No. 1 vicryl.
PROCEDURE	ACL Reconstruction	Anatomic ACL reconstruction using a four-strand autologous hamstring graft. If the diameter of the graft is found to be less than 7.5mm, semitendinosus will be tripled (5 strand graft) providing a greater graft diameter. Femoral tunnels will be drilled using an anteromedial portal technique, with femoral fixation provided by an Endobutton or equivalent. Tibial fixation will be provided by interference screw.

Timeline

• Start date: 2014-01-01
• Primary completion: 2025-03-01
• Completion: 2025-03-01
• First posted: 2013-12-23
• Last updated: 2024-01-08

Locations

8 sites across 3 countries: Belgium, Canada, United Kingdom