STABILITY 2: Anterior Cruciate Ligament Reconstruction +/- Lateral Tenodesis With Patellar vs Quad Tendon (NCT03935750)
Anterior Cruciate Ligament Reconstruction Using Bone Patellar Bone or Quad Tendon Autograft With or Without Lateral Extra-Articular Tenodesis in Individuals Who Are at High Risk of Graft Failure (STABILITY 2)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Stanford University — Redwood City, California
Age range: 14 Years to 25 Years
🧪 Interventions in This Study
- Anterior cruciate ligament reconstruction (ACLR) (PROCEDURE)
- Lateral extra-articular tenodesis (LET) (PROCEDURE)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (31 Sites)
Showing the first 25 of 31 sites.
- Stanford University — Redwood City, California
- University of California, San Francisco — San Francisco, California
- Orlando Health Jewett Orthopedic Institute — Orlando, Florida
- Med Center Health — Bowling Green, Kentucky
- University of Kentucky — Lexington, Kentucky
- Ochsner Clinic Foundation — Baton Rouge, Louisiana
- University of Michigan — Ann Arbor, Michigan
- University of Minnesota — Minneapolis, Minnesota
- Mayo Clinic — Rochester, Minnesota
- University of New Mexico — Albuquerque, New Mexico
- Hospital for Special Surgery — New York, New York
- Wake Forest University School of Medicine — Winston-Salem, North Carolina
- University of Pittsburgh — Pittsburgh, Pennsylvania
- The Rector and Visitors of the University of Virginia — Charlottesville, Virginia
- Banff Sport Medicine Clinic — Banff, Alberta
- University of Calgary Sport Medicine Centre — Calgary, Alberta
- Fraser Health Authority — New Westminster, British Columbia
- Pan Am Clinic — Winnipeg, Manitoba
- Nova Scotia Health Authority — Halifax, Nova Scotia
- McMaster University — Hamilton, Ontario
- Fowler Kennedy Sport Medicine Clinic — London, Ontario
- University of Ottawa — Ottawa, Ontario
- St. Michael's Hospital — Toronto, Ontario
- Aarhus University Hospital — Aarhus,
- Cologne-Merheim Medical Center, Klinik für Orthopädie, Unfallchirurgie und Sporttraumatologie — Cologne,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Anterior Cruciate Ligament Injury
- Bridge-Enhanced ACL Repair-Safety Study (BEAR Trial) — Boston, Massachusetts
- The BEAR III Trial for Bridge-Enhanced ACL (Anterior Cruciate Ligament) Restoration — San Diego, California
- Virtual Reality Mindfulness Meditation After ACL Reconstruction — Chapel Hill, North Carolina
Explore by condition: All Anterior Cruciate Ligament Injury clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.