ACL Reconstruction vs ACL + LET for ACL Tear

(STAbiLiTY Trial)

Not currently recruiting at 7 trial locations

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Western Ontario, Canada

Disqualifiers: Previous ACL reconstruction, multi-ligament injury, others

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

Compensation: Varies

Number of Visits: 3

Duration: Surgery and immediate postoperative period

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to enhance ACL surgery, focusing on young athletes in sports involving significant twisting and turning. It compares standard ACL Reconstruction with a version that includes an additional tendon repair on the knee's outside, known as Lateral Extra-Articular Tenodesis (LET). The goal is to determine if this added step reduces the risk of ACL re-tear. Suitable participants have an ACL-deficient knee and play competitive pivoting sports. As an unphased trial, it offers participants the chance to contribute to innovative surgical techniques that could improve recovery and sports performance.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these surgical techniques are safe?

Research has shown that adding a procedure called lateral extra-articular tenodesis (LET) to ACL reconstruction is generally safe. Studies indicate that this combined approach rarely causes side effects, and when it does, they are usually mild. LET is considered a strong option for reducing the risk of the new ligament tearing again after surgery. It also seems unlikely to cause other problems. This makes it a promising addition to standard ACL surgery, especially for individuals returning to sports that involve a lot of twisting and turning. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ACL + LET treatment because it combines standard ACL reconstruction with an innovative technique called lateral extra-articular tenodesis (LET). This addition aims to provide extra stability to the knee, potentially reducing the risk of re-injury, which is a significant concern with traditional ACL reconstruction alone. The combined approach could lead to better long-term outcomes for athletes and active individuals, offering a more robust solution for ACL tears.

What evidence suggests that this trial's treatments could be effective for ACL tears?

This trial will compare ACL Reconstruction alone with ACL Reconstruction plus Lateral Extra-Articular Tenodesis (LET). Research has shown that adding LET to ACL reconstruction might lead to better outcomes. Studies have found that patients with LET experience more stable knees and have a lower risk of graft re-tear compared to those with only ACL reconstruction. Specifically, one study found that 86% of patients with LET returned to their previous level of sports activity. Another study noted improved knee function just seven months after surgery for those with LET. Overall, LET seems to increase the likelihood of returning to sports and reduce the risk of needing another surgery. ^{1 6 7 8 9}

Who Is on the Research Team?

Alan Getgood, MD

Principal Investigator

University of Western Ontario, Canada

Dianne Bryant, Phd

Principal Investigator

University of Western Ontario, Canada

Are You a Good Fit for This Trial?

This trial is for individuals aged up to 25 with an ACL deficient knee who play competitive pivoting sports. They must have a significant pivot shift in the knee (grade 2 or higher) and some general ligament looseness, as indicated by a Beighton score of at least 4.

Inclusion Criteria

You have a condition where your joints are very flexible, measured by a specific score.

I am between the ages when bones stop growing and 25 years old.

My knee is unstable when it rotates.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ACL reconstruction surgery, with or without lateral extra-articular tenodesis

Surgery and immediate postoperative period

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Regular follow-up visits at 3, 6, 12, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview The study compares usual ACL reconstructive surgery against ACL reconstruction combined with lateral extra-articular tenodesis (LET), which adds extra tendon repair outside the knee, to see if it better prevents graft failure.

How Is the Trial Designed?

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?

University of Western Ontario, Canada

Lead Sponsor

Trials

168

Recruited

320,000+

Orthopedic Research and Education Foundation

Collaborator

Trials

23

Recruited

6,200+

International Society of Arthroscopy Knee Surgery and Orthopedic Sports Medicine

Collaborator

Trials

1

Recruited

620+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9239354/

Lateral extra-articular tenodesis and anterior cruciate ... Clinical scores at follow-up were satisfactory in the study group, and 86% of patients could return to their pre-injury sports level. Furthermore, in this study ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12086805/

Lateral extra‐articular tenodesis improves functional ... The main finding of this study was that the addition of a LET in ACLR patients increased their functional outcomes after 7 months with no ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0749806322007769

Meta-analyses Combined Lateral Extra-Articular Tenodesis ... ACL + ALLR were found to have significantly better outcomes in terms of knee rotational stability and graft failure rate than isolated ACL reconstructions.

4. ijspt.scholasticahq.com ijspt.scholasticahq.com/article/94015-why-your-patient-may-need-an-acl-reconstruction-plus-lateral-extra-articular-tenodesis-procedure

Why Your Patient May Need an ACL Reconstruction Plus ... The benefits of adding an LET procedure to an ACL surgery may include greater rotational stability, decreased re-tear rates, and improved return to play.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2059775424000749?dgcid=rss_sd_all

Lateral extra-articular tenodesis may be more cost-effective ... There were 77 total ACL graft failures with comparable failure rates between patients receiving LET versus ALLR (2.9% vs. 3.2%, P=0.690). The average QALYs ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12063374/

Are there any complications after lateral extra-articular ... The analysed studies show that combining LET with ACLR appears to be a safe procedure associated with infrequent and mild side effects.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1060187225000048

Lateral Extra-Articular Tenodesis in the Young Athlete Promising findings suggest that LET is a strong option to reduce the risk of ACL graft rupture with low risk for additional complications.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03935750

STABILITY 2: Anterior Cruciate Ligament Reconstruction + ... Anterior cruciate ligament reconstruction (ACLR) is complicated by high failure rates in young, active individuals, which is associated with worse outcomes and ...

9. arthroscopytechniques.org arthroscopytechniques.org/article/S2212-6287(25)00286-5/fulltext

Minimally Invasive Lateral Extra-Articular Tenodesis Using ... Lateral extra-articular tenodesis has been introduced as an adjunct to improve rotational stability and reduce graft failure risk. This ...