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Procedure
ACL Reconstruction With/Without LET for ACL Injury (STABILITY 2 Trial)
N/A
Recruiting
Led By Volker Musahl, MD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
An ACL-deficient knee
Age 14-25
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months (at 1.5, 3, 6, 12 and 24 months)
Awards & highlights
STABILITY 2 Trial Summary
This trial will help determine if a lateral extra-articular tenodesis (LET) may provide greater stability to the ACLR, and if so, what the effect on failure rate is.
Who is the study for?
This trial is for young, active individuals aged 14-25 with a fully mature skeleton and an ACL-deficient knee. They must participate in sports that involve pivoting or have certain knee conditions like a pivot shift of grade 2+ or ligamentous laxity. People can't join if they've had previous ACL surgery, multiple ligament injuries needing surgery, inflammatory joint diseases, are pregnant, or cannot consent.Check my eligibility
What is being tested?
The STABILITY 2 trial is testing two types of grafts used in ACL reconstruction—patellar tendon and quadriceps tendon—and whether adding lateral extra-articular tenodesis (LET) affects the re-injury rate. It's a randomized study involving over a thousand patients to determine the best surgical approach.See study design
What are the potential side effects?
Potential side effects may include pain at the graft site, swelling, stiffness in the knee joint, infection risk from surgery, and concerns about developing osteoarthritis in the lateral compartment due to LET.
STABILITY 2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My knee lacks a functioning ACL.
Select...
I am between 14 and 25 years old.
STABILITY 2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months (at 1.5, 3, 6, 12 and 24 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months (at 1.5, 3, 6, 12 and 24 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
ACL Clinical Failure
Secondary outcome measures
ACL-Quality of Life (QOL) Questionnaire
Adverse events
Donor site morbidity - Anterior Kneeling Pain
+11 moreSTABILITY 2 Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: QT + LETExperimental Treatment2 Interventions
Patients will undergo ACLR using a quadriceps tendon (QT) autograft with LET.
Group II: BPTB + LETExperimental Treatment2 Interventions
Patients will undergo anterior cruciate ligament reconstruction (ACLR) using a bone patellar bone tendon (BPTB) autograft with lateral extra-articular tenodesis (LET).
Group III: QT aloneActive Control1 Intervention
Patients will undergo ACLR using a QT autograft without LET.
Group IV: BPTB aloneActive Control1 Intervention
Patients will undergo ACLR using a BPTB autograft without LET.
Find a Location
Who is running the clinical trial?
University of PittsburghLead Sponsor
1,722 Previous Clinical Trials
16,341,700 Total Patients Enrolled
1 Trials studying Anterior Cruciate Ligament Reconstruction
University of Western Ontario, CanadaOTHER
164 Previous Clinical Trials
318,010 Total Patients Enrolled
1 Trials studying Anterior Cruciate Ligament Reconstruction
624 Patients Enrolled for Anterior Cruciate Ligament Reconstruction
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
484 Previous Clinical Trials
1,085,771 Total Patients Enrolled
1 Trials studying Anterior Cruciate Ligament Reconstruction
40 Patients Enrolled for Anterior Cruciate Ligament Reconstruction
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need treatment for a painful joint surface problem, not just cleaning.My legs are unevenly bent inward more than 3 degrees.I have had ACL reconstruction surgery on one of my knees.I have a type of joint inflammation.I need surgery for injuries to two or more ligaments.I am unable to give consent by myself.My knee lacks a functioning ACL.I have a partial tear in my ACL needing surgery, but the rest is intact.I play a sport that involves quick turns, have a knee that gives way, or my joints are very flexible.I am between 14 and 25 years old.
Research Study Groups:
This trial has the following groups:- Group 1: BPTB + LET
- Group 2: QT + LET
- Group 3: QT alone
- Group 4: BPTB alone
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Anterior Cruciate Ligament Reconstruction Patient Testimony for trial: Trial Name: NCT03935750 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research inquiry accept geriatric participants?
"For this medical research, the age of participants must be between 14 and 25 years old."
Answered by AI
How many individuals are currently taking part in this medical experiment?
"This clinical trial needs 1236 participants who meet the predefined eligibility criteria. Patients have the option of participating from Wake Forest University School of Medicine in Winston-Salem, North carolina and Mayo Clinic in Rochester, Minnesota."
Answered by AI
Are there vacant spaces for potential participants in this clinical experiment?
"Correct. The clinicaltrials.gov website reveals that this medical investigation is presently searching for participants, with the first post date on July 28th 2020 and last update of September 21st 2022. 1236 volunteers are needed from 22 different research sites."
Answered by AI
Are there any other facilities conducting this research endeavor within the state?
"22 medical sites have been identified as operating for this research, with prominent examples being Wake Forest University School of Medicine (Winston-Salem), Mayo Clinic (Rochester) and McMaster University (Hamilton)."
Answered by AI
Who is eligible to sign up for this clinical trial?
"This clinical trial is recruiting 1236 participants between the ages of 14 and 25 with a history of joint instability."
Answered by AI
Who else is applying?
What state do they live in?
Vermont
North Carolina
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I'm hoping to avoid a total knee replacement.
PatientReceived 1 prior treatment
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