LET + ACL Reconstruction for Knee Injuries

(STABILITY LTF Trial)

Recruiting at 7 trial locations

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Western University, Canada

Disqualifiers: Previous ACL reconstruction, Multi-ligament injury, Symptomatic cartilage defect, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Not specified

510 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment LET + ACL Reconstruction for knee injuries?

Research shows that adding Lateral Extra-Articular Tenodesis (LET) to ACL Reconstruction improves knee function and reduces the chance of graft failure compared to ACL Reconstruction alone. ^{1 2 3 4 5}

Is the combination of LET and ACL reconstruction safe for humans?

There is concern that combining LET with ACL reconstruction might affect the knee joint's mechanics and potentially lead to joint wear over time, but specific safety data in humans is not provided in the available research. ^{1 2 3 6 7}

How is the treatment LET + ACL Reconstruction different from other treatments for knee injuries?

The combination of Lateral Extra-Articular Tenodesis (LET) with ACL Reconstruction is unique because it specifically targets and reduces anterolateral rotatory instability, which is a type of knee instability that can persist even after standard ACL reconstruction. This approach aims to provide better control of knee rotation and potentially improve clinical outcomes compared to ACL reconstruction alone. ^{1 2 3 5 8}

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for individuals aged up to 25 with an ACL deficient knee, who play competitive pivoting sports and have a significant pivot shift in the knee or general ligament laxity. It's not suitable for those outside of these criteria.

Inclusion Criteria

My knee is unstable when it rotates.

I am between the ages when my bones have stopped growing and 25 years old.

My knee lacks a functioning ACL.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo anterior cruciate ligament reconstruction (ACLR) with or without a lateral extraarticular tenodesis (LET)

Not specified

Follow-up

Participants are monitored for the development of osteoarthritis and other outcomes using imaging and patient-reported outcomes over a 10-year period

10 years

Treatment Details

Interventions

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

Trial Overview The study examines long-term effects of adding Lateral Extra-Articular Tenodesis (LET) to Anterior Cruciate Ligament Reconstruction (ACLR). It aims to determine if LET increases the risk of developing osteoarthritis over a decade.

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?

Western University, Canada

Lead Sponsor

Trials

270

Recruited

62,500+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

High Risk of Tunnel Convergence in Combined Anterior Cruciate Ligament Reconstruction and Lateral Extra-articular Tenodesis. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Revision Anterior Cruciate Ligament Reconstruction Using Bone-Patellar Tendon-Bone Graft Combined With Modified Lemaire Technique Versus Hamstring Graft Combined With Anterolateral Ligament Reconstruction: A Clinical Comparative Matched Study With a Mean Follow-up of 5 Years From The SANTI Study Group. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Editorial Commentary: Knee Lateral Extra-articular Tenodesis. [2018]

4. Germany pubmed.ncbi.nlm.nih.gov

Functional Outcome of Lateral Extraarticular Tenodesis (LET) Procedure in Addition to Anterior Cruciate Ligament Reconstruction: A Metaanalysis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Lateral Extra-articular Tenodesis Reduces Rotational Laxity When Combined With Anterior Cruciate Ligament Reconstruction: A Systematic Review of the Literature. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Radiographic Landmarks for Femoral Tunnel Positioning in Lateral Extra-articular Tenodesis Procedures. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Lateral Extra-articular Tenodesis Alters Lateral Compartment Contact Mechanics under Simulated Pivoting Maneuvers: An In Vitro Study. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

The Role of Lateral Extra-articular Tenodesis in Anterior Cruciate Ligament Reconstruction and Treatment of Rotatory Knee Instability: a Scoping Review. [2023]