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Stability 2: ACL Reconstruction +/- Lateral Tenodesis with Patellar vs Quad Tendon (Protocol # PRO19020231)

Recruiting

STABILITY 2 is a 21-site multicenter, international, randomized clinical trial that will randomly assign 1236 individuals with an anterior cruciate ligament (ACL) deficient knee who are at high risk of re-injury to anatomic anterior cruciate ligament reconstruction (ACLR) using bone patellar tendon bone (BPTB) or quadriceps tendon (QT) autograft with or without a lateral extra-articular tenodesis (LET).

I'm interested

All
14 Years to 25 Years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Age 14-25,
• An ACL-deficient knee,
• Skeletal maturity (i.e. closed epiphyseal growth plates on standard knee radiographs),
• At least two of the following: participate in a competitive pivoting sport; have a pivot shift of grade 2 or greater; have generalized ligamentous laxity (Beighton score of ≥4) and/or genu recurvatum >10 degrees.
Exclusion Criteria:

• Previous ACLR on either knee,
• Partial ACL injury (defined as one bundle ACL tear requiring reconstruction/augmentation of the torn bundle with no surgery required for the intact bundle),
• Multiple ligament injury (two or more ligaments requiring surgery),
• Symptomatic articular cartilage defect requiring treatment other than debridement,
• >3 degrees of asymmetric varus,
• Inflammatory arthropathy,
• Inability to provide consent,
• Pregnancy at baseline.

Procedure: Anterior cruciate ligament reconstruction (ACLR), Procedure: Lateral extra-articular tenodesis (LET)

Anterior Cruciate Ligament Injury, Anterior Cruciate Ligament Reconstruction, Joint Instability, Bone, Joint & Muscle

Lateral extra-articular tenodesis, Autografting, Allografting, Bone-Patellar Tendon-Bone Grafting, Clinics and Surgery Center (CSC)

Michele (Shelly) Paipal-Umland - paipa002@umn.edu
Jeffrey Macalena
N/A
STUDY00010820
NCT03935750
See this study on ClinicalTrials.gov

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