Long-term Follow up of the Stability 1 Trial

Overview

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.

Interventions

• 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 t
• 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.

Primary outcome measures

• Lateral compartment knee OA [Time frame: 10 Years]
• Region-specific quality of life using the Knee Osteoarthritis and outcomes Score (KOOS) [Time frame: 10 Years]

Secondary outcome measures (9)

• Disease-specific quality of life using the ACL Quality of Life Questionnaire (ACL-QOL) [Time frame: 10 Years]
• The Marx Activity Rating Scale (MARS) [Time frame: 10 Years]
• Subjective symptoms, function and activity (IKDC) [Time frame: 10 Years]
• MRI [Time frame: 10 Years]
• Patient Reported Quality of Life (ACL QOL) [Time frame: 10 Years]
• 4-Item Pain Intensity Measure (P4) [Time frame: 10 Years]
• Clinical Failure [Time frame: 10 Years]
• Objective Functional Measures [Time frame: 10 Years]
• Adverse Events [Time frame: 10 Years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Diagnostic

Study locations

Canada · 7 centers

• Banff Sport Medicine Clinic — Banff
• University of Calgary — Calgary
• Fraser Health Authority — New Westminster
• Pan Am Clinic — Winnipeg
• McMaster University — Hamilton
• Queens University — Kingston
• Fowler Kennedy Sport Medicine Clinic — London

United Kingdom · 1 center

• University Hospitals Coventry and Warwickshire NHS Trust — Coventry

Identifiers

NCT: NCT06885372 · 104524

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗