Comparing graft types for ACL reconstruction with or without lateral tenodesis
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)
This study is testing which type of graft works best for ACL reconstruction in young, active people aged 14-25 to help them recover and get back to sports safely.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1236 (estimated) |
| Ages | 14 Years to 25 Years |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 31 sites (Redwood City, California and 30 other locations) |
| Trial ID | NCT03935750 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of different graft types (bone-patellar-tendon-bone, quadriceps tendon, and hamstring tendon) in anterior cruciate ligament reconstruction (ACLR) with or without lateral extra-articular tenodesis (LET). The study focuses on young, active individuals aged 14-25 who have suffered an ACL injury, assessing outcomes such as graft failure rates, return to sports, donor site morbidity, and the risk of developing osteoarthritis. By comparing these graft options, the trial seeks to identify the best approach to improve long-term outcomes and reduce the risk of re-injury.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 14-25 with an ACL-deficient knee who are active in competitive pivoting sports.
Not a fit: Patients who have previously undergone ACL reconstruction or have multiple ligament injuries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical techniques and graft choices that enhance recovery and reduce re-injury rates for young athletes.
How similar studies have performed: While there have been studies on ACL reconstruction techniques, this trial is significant as it specifically compares the effectiveness of different graft types in a young, active population, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Redwood City, California and 30 other locations
- Stanford University — Redwood City, California, United States (Recruiting)
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
- Orlando Health Jewett Orthopedic Institute — Orlando, Florida, United States (Recruiting)
- Med Center Health — Bowling Green, Kentucky, United States (Recruiting)
- University of Kentucky — Lexington, Kentucky, United States (Recruiting)
- Ochsner Clinic Foundation — Baton Rouge, Louisiana, United States (Recruiting)
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
- University of New Mexico — Albuquerque, New Mexico, United States (Recruiting)
- Hospital for Special Surgery — New York, New York, United States (Recruiting)
- Wake Forest University School of Medicine — Winston-Salem, North Carolina, United States (Recruiting)
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
- The Rector and Visitors of the University of Virginia — Charlottesville, Virginia, United States (Active_not_recruiting)
- Banff Sport Medicine Clinic — Banff, Alberta, Canada (Recruiting)
- University of Calgary Sport Medicine Centre — Calgary, Alberta, Canada (Recruiting)
- Fraser Health Authority — New Westminster, British Columbia, Canada (Recruiting)
- Pan Am Clinic — Winnipeg, Manitoba, Canada (Recruiting)
- Nova Scotia Health Authority — Halifax, Nova Scotia, Canada (Recruiting)
- McMaster University — Hamilton, Ontario, Canada (Recruiting)
- Fowler Kennedy Sport Medicine Clinic — London, Ontario, Canada (Recruiting)
- University of Ottawa — Ottawa, Ontario, Canada (Recruiting)
- St. Michael's Hospital — Toronto, Ontario, Canada (Recruiting)
- Aarhus University Hospital — Aarhus, Denmark (Recruiting)
- Cologne-Merheim Medical Center, Klinik für Orthopädie, Unfallchirurgie und Sporttraumatologie — Cologne, Germany (Recruiting)
- University Klinik Münster — Münster, Germany (Recruiting)
- Dublin City University / UPMC Sports Surgery Clinic — Dublin, Dublin 9, Ireland (Recruiting)
- Oslo University Hospital — Oslo, Norway (Recruiting)
- Stockholm South Hospital, Karolinska Institutet — Stockholm, Sweden (Recruiting)
- North Bristol Trust — Bristol, United Kingdom (Recruiting)
- University Hospitals Coventry and Warwickshire NHS Trust — Coventry, United Kingdom (Recruiting)
Study contacts
- Principal investigator: James J Irrgang, PT PhD FAPTA — University of Pittsburgh
- Study coordinator: Stacey Wanlin
- Email: swanlin@uwo.ca
- Phone: 519-661-2111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.