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STABILITY 2: Anterior Cruciate Ligament Reconstruction +/- Lateral Tenodesis With Patellar vs Quad Tendon
Sponsor: University of Pittsburgh
Summary
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 1236 young, active patients at high risk of re-injury to undergo ACLR using BPTB or QT autograft with our without LET.
Official title: 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)
Key Details
Gender
All
Age Range
14 Years - 25 Years
Study Type
INTERVENTIONAL
Enrollment
1236
Start Date
2020-07-28
Completion Date
2026-02-28
Last Updated
2026-01-29
Healthy Volunteers
No
Conditions
Interventions
Anterior cruciate ligament reconstruction (ACLR)
All participants will undergo an anatomic ACLR with either a BPTB or QT autograft, as randomized.
Lateral extra-articular tenodesis (LET)
Participants randomized to the BPTB or QT arms will be randomized a second time to a LET procedure or no additional surgery.
Locations (31)
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
University Klinik Münster
Münster, Germany
Dublin City University / UPMC Sports Surgery Clinic
Dublin, Dublin 9, Ireland
Oslo University Hospital
Oslo, Norway
Stockholm South Hospital, Karolinska Institutet
Stockholm, Sweden
North Bristol Trust
Bristol, United Kingdom
University Hospitals Coventry and Warwickshire NHS Trust
Coventry, United Kingdom