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Procedure

ACL + LET for Anterior Cruciate Ligament Reconstruction (STAbiLiTY Trial)

N/A

Waitlist Available

Led By Alan Getgood, MD

Research Sponsored by University of Western Ontario, Canada

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

skeletally mature to 25 years of age

grade 2 pivot shift or greater

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3, 6, 12, 24 months

Awards & highlights

STAbiLiTY Trial Summary

This trial is comparing two types of surgeries for patients with a knee injury called anterior cruciate ligament (ACL) tear. One surgery is the usual ACL reconstructive surgery, and the other surgery includes

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include pain at the surgery site, swelling, stiffness in the knee joint, weakness or loss of strength in surrounding muscles, and complications related to graft failure or healing.

STAbiLiTY Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My knee is unstable when it rotates.

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My knee lacks a functioning ACL.

STAbiLiTY Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3, 6, 12, 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3, 6, 12, 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3, 6, 12, 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Graft Failure

Secondary outcome measures

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

MARX Activity Rating Scale

Passive knee extension and active-assisted knee flexion

+4 more

STAbiLiTY Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ACL + LETExperimental Treatment2 Interventions

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

Group II: ACL ReconstructionActive Control1 Intervention

Standard ACL reconstruction only.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ACL Reconstruction

2016

N/A

~20

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Orthopedic Research and Education FoundationOTHER

19 Previous Clinical Trials

10,776 Total Patients Enrolled

University of Western Ontario, CanadaLead Sponsor

164 Previous Clinical Trials

318,622 Total Patients Enrolled

1 Trials studying Anterior Cruciate Ligament Reconstruction

1,236 Patients Enrolled for Anterior Cruciate Ligament Reconstruction

International Society of Arthroscopy Knee Surgery and Orthopedic Sports MedicineUNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients currently eligible to participate in this ongoing clinical trial?

"According to the information available on clinicaltrials.gov, this particular study is not currently seeking participants. The trial was initially posted on January 1st, 2014 and underwent its last update on September 25th, 2017. However, it's worth noting that there are presently eleven other ongoing clinical trials actively searching for eligible candidates."

Answered by AI

Is the eligibility criteria for this research study inclusive of individuals under the age of 35?

"To be eligible for this research study, candidates must fall within the age range of 14 to 25 years old."

Answered by AI

Which individuals are eligible to participate in this clinical research study?

"For this clinical trial, we are seeking to enlist 624 individuals aged between 14 and 25 who have undergone anterior cruciate ligament reconstruction. The key eligibility criteria include having an ACL deficient knee, being skeletally mature up to the age of 25, participating in a competitive pivoting sport, experiencing a grade 2 pivot shift or higher, and demonstrating generalized ligament laxity with a Beighton score of at least 4."

Answered by AI

Are there a substantial number of medical facilities in North America conducting this clinical trial?

"Several esteemed institutions, such as McMaster University in Hamilton, Fraser Health Authority in New Westminster, and Antwerp Orthopedic Center in Antwerp, are among the 8 locations where patient enrollment is currently taking place for this trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Standard ACL Reconstruction vs ACL + Lateral Extra-Articular Tenodesis Study

2014. "Standard ACL Reconstruction vs ACL + Lateral Extra-Articular Tenodesis Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02018354.

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