STABILITY 2: Anterior Cruciate Ligament Reconstruction +/- Lateral Tenodesis With Patellar vs Quad Tendon
Running, not enrolling · Not applicable
Conditions studied: Anterior Cruciate Ligament Injury, Anterior Cruciate Ligament Reconstruction, Joint Instability
In brief
Anterior cruciate ligament (ACL) rupture is one of the most common musculoskeletal injuries in young individuals, particularly those that are active in sports. Up to 30% of individuals under the age of 20 years suffer a re-injury to the reconstructed ACL. Revision ACLR has been associated with degeneration of the articular cartilage and increased rates of meniscal tears, increasing the risk of post-traumatic osteoarthritis (PTOA), additional surgical procedures, reduced physical function and quality of life. As such, strategies to reduce ACLR failure, particularly in young active individuals, are critical to improving short and long-term outcomes after ACL rupture. There is ongoing debate about the optimal graft choice and reconstructive technique. Three autograft options are commonly used, including the bone-patellar-tendon-bone (BPTB), quadriceps tendon (QT) and hamstring tendon (HT). Additionally, a lateral extra-articular tenodesis (LET) may provide greater stability to the ACLR; however, its effect on failure rate is unclear and surgery-induced lateral compartment OA is a concern. To definitively inform the choice of autograft and the need for a LET, this multicenter, international randomized clinical trial will randomly assign 1292 young, active patients at high risk of re-injury to undergo ACLR using BPTB or QT autograft with our without LET.
Key facts
- Study ID
- NCT03935750
- Run by
- University of Pittsburgh
- People needed
- 1272
- Starts
- 2020-07-28
- Expected to finish
- 2028-05-31
- Last updated by the study team
- 2026-06-17
Who can join
Age: 14 and older, up to 25. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Stanford University — Redwood City, California, United States
- University of California, San Francisco — San Francisco, California, United States
- Orlando Health Jewett Orthopedic Institute — Orlando, Florida, United States
- Med Center Health — Bowling Green, Kentucky, United States
- University of Kentucky — Lexington, Kentucky, United States
- Ochsner Clinic Foundation — Baton Rouge, Louisiana, United States
- University of Michigan — Ann Arbor, Michigan, United States
- University of Minnesota — Minneapolis, Minnesota, United States
- Mayo Clinic — Rochester, Minnesota, United States
- University of New Mexico — Albuquerque, New Mexico, United States
- Hospital for Special Surgery — New York, New York, United States
- Wake Forest University School of Medicine — Winston-Salem, North Carolina, United States
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States
- The Rector and Visitors of the University of Virginia — Charlottesville, Virginia, United States
- Banff Sport Medicine Clinic — Banff, Alberta, Canada
- University of Calgary Sport Medicine Centre — Calgary, Alberta, Canada
- Fraser Health Authority — New Westminster, British Columbia, Canada
- Pan Am Clinic — Winnipeg, Manitoba, Canada
- Nova Scotia Health Authority — Halifax, Nova Scotia, Canada
- McMaster University — Hamilton, Ontario, Canada
- Fowler Kennedy Sport Medicine Clinic — London, Ontario, Canada
- University of Ottawa — Ottawa, Ontario, Canada
- St. Michael's Hospital — Toronto, Ontario, Canada
- Aarhus University Hospital — Aarhus, Denmark
- Cologne-Merheim Medical Center, Klinik für Orthopädie, Unfallchirurgie und Sporttraumatologie — Cologne, Germany
Full record on ClinicalTrials.gov
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