Standard ACL Reconstruction vs ACL + Lateral Extra-Articular Tenodesis Study (STAbiLiTY)

University of Western Ontario, Canada

Status: Active, not recruiting

Conditions: Anterior Cruciate Ligament Reconstruction

Treatments: Procedure: ACL Reconstruction; Procedure: Lateral Extra-Articular Tenodesis (LET)

Study type: Interventional

Funder types: Other

Identifiers

NCT02018354

REB# 104524

Details and patient eligibility

About

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.

Full 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.

Enrollment: 624 patients

Sex: All

Ages: 14 to 25 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ACL deficient knee

• skeletally mature to 25 years of age

• 2 or more of:

  • competitive pivoting sport
  • grade 2 pivot shift or greater
  • generalized ligament laxity - Beighton score of 4 or greater

Exclusion criteria

• previous ACL reconstruction on either knee
• multi-ligament injury (two or more ligaments requiring surgical attention)
• symptomatic articular cartilage defect requiring treatment other than debridement
• greater than 3 degrees of asymmetric varus
• unable to complete outcome questionnaires

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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624 participants in 2 patient groups

ACL Reconstruction

Active Comparator group

Description:

Standard ACL reconstruction only.

Treatment:

Procedure: ACL Reconstruction

ACL + LET

Experimental group

Description:

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

Treatment:

Procedure: ACL Reconstruction

Procedure: Lateral Extra-Articular Tenodesis (LET)