STABILITY 2: Anterior Cruciate Ligament Reconstruction +/- Lateral Tenodesis With Patellar vs Quad Tendon

Overview

About this study

The overall primary objective of this 21-site international randomized trial is to determine if graft type (QT, BPTB or HT) with or without a lateral extra-articular tenodesis (LET) will affect the rate of Anterior Cruciate Ligament (ACL) clinical failure 2 years after surgery.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Eligibility last updated 9/23/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Aaron Krych, M.D.	Open for enrollment	Contact information: Sejal Dave (507) 266-9085 Dave.Sejal@mayo.edu

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Aaron Krych, M.D.

Open for enrollment

Contact information:

Sejal Dave

(507) 266-9085

Dave.Sejal@mayo.edu

More information

Publications

Publications are currently not available

Clinical Trials