ACL Reconstruction vs ACL + LET for ACL Tear

(STAbiLiTY Trial)

Recruiting at 7 trial locations

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Western Ontario, Canada

Disqualifiers: Previous ACL reconstruction, multi-ligament injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: Surgery and immediate postoperative period

624 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Alan Getgood, MD

Principal Investigator

University of Western Ontario, Canada

Dianne Bryant, Phd

Principal Investigator

University of Western Ontario, Canada

Eligibility Criteria

This trial is for individuals aged up to 25 with an ACL deficient knee who play competitive pivoting sports. They must have a significant pivot shift in the knee (grade 2 or higher) and some general ligament looseness, as indicated by a Beighton score of at least 4.

Inclusion Criteria

You have a condition where your joints are very flexible, measured by a specific score.

I am between the ages when bones stop growing and 25 years old.

My knee is unstable when it rotates.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ACL reconstruction surgery, with or without lateral extra-articular tenodesis

Surgery and immediate postoperative period

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Regular follow-up visits at 3, 6, 12, and 24 months

Treatment Details

Interventions

• ACL Reconstruction
• Lateral Extra-Articular Tenodesis (LET)

Trial Overview The study compares usual ACL reconstructive surgery against ACL reconstruction combined with lateral extra-articular tenodesis (LET), which adds extra tendon repair outside the knee, to see if it better prevents graft failure.

Participant Groups

Group I: ACL + LET Experimental Treatment 2 Interventions

Anatomic ACL reconstruction following the same procedure as the active comparator group with an added lateral extra-articular tenodesis (LET).

Group II: ACL Reconstruction Active Control 1 Intervention

Standard ACL reconstruction only.

Who Is Running the Clinical Trial?

University of Western Ontario, Canada

Lead Sponsor

Trials

168

Recruited

320,000+

Orthopedic Research and Education Foundation

Collaborator

Trials

23

Recruited

6,200+

International Society of Arthroscopy Knee Surgery and Orthopedic Sports Medicine

Collaborator

Trials

1

Recruited

620+