Long-term Follow Up of the Stability 1 Trial (STABILITY LTF)

Western University, Canada

Status: Invitation-only

Conditions: Osteoarthritis (OA) of the Knee; LET; ACL Reconstruction

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06885372

104524

Details and patient eligibility

About

From 2014-2017, across 7 Canadian and 2 European sites, we randomized 618 patients at high-risk of re-injury, to anterior cruciate ligament reconstruction (ACLR) with or without a lateral extraarticular tenodesis (LET) and demonstrated that the addition of the LET reduced the risk of instability (RRR=0.38; 95% Confidence Interval (CI), 0.21-0.52; P=0.0001) and graft re-rupture (RRR, 0.67; 95% CI, 0.36-0.83; P=0.001). As a result, practice has changed; there has been a large increase in the proportion of orthopaedic surgeons recommending the addition of an LET at the time of ACLR and an increase in the number of patients requesting an LET from their surgeon. There is some weak evidence suggesting that in the longer term, the LET may increase the risk of developing osteoarthritis (OA) in that knee. Knee OA affects over 4.4 million Canadians and the number of younger adults being diagnosed with knee OA is growing and is a primary reason for seeking healthcare in Canada. The impact of OA in Canada is enormous and projected to cost Canada $17.5 billion annually in lost productivity alone by 2031. This study will use imaging and patient-reported Knee Outcomes Osteoarthritis Score (KOOS) to evaluate the incidence of OA at 10-years post ACL reconstruction with and without LET. We will also collect information about overall knee health, patient-reported outcomes, costs associated with knee injury, rehabilitation and disability, clinical failure, functional ability, and sport participation. It is crucial that we understand the risks of developing knee OA associated with the addition of an LET to an ACLR so that surgeons and patients can make informed decisions, not just for their immediate post injury treatment of the failed ligament, but for the potential long-term consequences of that decision.

Enrollment: 510 estimated 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: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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510 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)