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Procedure

ACL Reconstruction With/Without LET for ACL Injury (STABILITY 2 Trial)

N/A

Recruiting

Led By Dianne M Bryant, PhD

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

Must not have

Multiple ligament injury (two or more ligaments requiring surgery)

Symptomatic articular cartilage defect requiring treatment other than debridement

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months (at 1.5, 3, 6, 12 and 24 months)

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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My knee lacks a functioning ACL.

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I am between 14 and 25 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need surgery for injuries to two or more ligaments.

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I need treatment for a painful joint surface problem, not just cleaning.

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My legs are unevenly bent inward more than 3 degrees.

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I have had ACL reconstruction surgery on one of my knees.

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I have a type of joint inflammation.

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I am unable to give consent by myself.

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I have a partial tear in my ACL needing surgery, but the rest is intact.

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months (at 1.5, 3, 6, 12 and 24 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

ACL Clinical Failure

Secondary study objectives

ACL-Quality of Life (QOL) Questionnaire

Adverse events

Donor site morbidity - Anterior Kneeling Pain

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 9Eligibility criteria met