Long-term Follow up of the Stability 1 Trial

NCT06885372 | Enrolling By Invitation

• 1 other identifier: 104524
• Study Type: interventional
• Target: 510
• Locations: 2 countries
• Sites: 8

Brief Summary

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.

Conditions

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

Keywords

ACL; ACL injuries; ACL reconstruction; LET; Osteoarthritis; Knee osteoarthritis; Orthopaedics; Anterolateral ligament; Lateral Extra-articular Tenodesis (LET)

Outcome Measures

Primary Outcomes (2)

• Lateral compartment knee OA

  As was conducted at baseline and two years postoperative in the Stability 1 study, patients will undergo a standing semi-flexed posterior to anterior (PA) radiograph of both knees.

  10 Years

• Region-specific quality of life using the Knee Osteoarthritis and outcomes Score (KOOS)

  The KOOS is a 42-item knee-specific questionnaire with five separately reported domains, including pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sports/recreation (5 items) and knee-related quality of life (4 items). Domain scores represent the average of all items in the domain standardized to a score from 0 to 100 (worst to best). This instrument has face validity and has demonstrated construct validity, excellent test-retest reliability for each domain (range, 0.75 to 0.93) and has been shown to be responsive to change in patients undergoing ACLR.

  10 Years

Secondary Outcomes (9)

• Disease-specific quality of life using the ACL Quality of Life Questionnaire (ACL-QOL)

  10 Years

• The Marx Activity Rating Scale (MARS)

  10 Years

• Subjective symptoms, function and activity (IKDC)

  10 Years

• MRI

  10 Years

• Patient Reported Quality of Life (ACL QOL)

  10 Years

Study Arms (2)

ACL Reconstruction

ACTIVE COMPARATOR

Standard ACL reconstruction only.

Procedure: ACL Reconstruction

ACL + LET

EXPERIMENTAL

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

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

Interventions

Lateral Extra-Articular Tenodesis (LET) PROCEDURE

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.

ACL + LET

ACL Reconstruction PROCEDURE

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.

ACL + LET; ACL Reconstruction

Eligibility Criteria

• Age: 14 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• ACL deficient knee
• skeletally mature to 25 years of age
• or more of:
• competitive pivoting sport
• grade 2 pivot shift or greater
• generalized ligament laxity - Beighton score of 4 or greater

You may not qualify if:

• 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

Sponsors & Collaborators

• Western University, Canada: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (8)

Banff Sport Medicine Clinic

Banff, Alberta, T1L 1B3, Canada

Location

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

Fraser Health Authority

New Westminster, British Columbia, V3L 5P5, Canada

Location

Pan Am Clinic

Winnipeg, Manitoba, R3M 3E4, Canada

Location

McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

Location

Queens University

Kingston, Ontario, K7L 2V7, Canada

Location

Fowler Kennedy Sport Medicine Clinic

London, Ontario, N6A 3K7, Canada

Location

University Hospitals Coventry and Warwickshire NHS Trust

Coventry, CV2 2DX, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis; Anterior Cruciate Ligament Injuries; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Knee Injuries; Leg Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 20, 2025
• Study Start: November 1, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 20, 2025

Record last verified: 2025-02

Locations

CA (7); GB (1)