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)

Status: Recruiting
Location: See all (31) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 14
Maximum Age: 25
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
Stanford University
RECRUITING
Redwood City
University of California, San Francisco
RECRUITING
San Francisco
Florida
Orlando Health Jewett Orthopedic Institute
RECRUITING
Orlando
Kentucky
Med Center Health
RECRUITING
Bowling Green
University of Kentucky
RECRUITING
Lexington
Louisiana
Ochsner Clinic Foundation
RECRUITING
Baton Rouge
Michigan
University of Michigan
RECRUITING
Ann Arbor
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Mayo Clinic
RECRUITING
Rochester
North Carolina
Wake Forest University School of Medicine
RECRUITING
Winston-salem
New Mexico
University of New Mexico
RECRUITING
Albuquerque
New York
Hospital for Special Surgery
RECRUITING
New York
Pennsylvania
University of Pittsburgh
RECRUITING
Pittsburgh
Virginia
The Rector and Visitors of the University of Virginia
ACTIVE_NOT_RECRUITING
Charlottesville
Other Locations
Canada
Banff Sport Medicine Clinic
RECRUITING
Banff
University of Calgary Sport Medicine Centre
RECRUITING
Calgary
Nova Scotia Health Authority
RECRUITING
Halifax
McMaster University
RECRUITING
Hamilton
Fowler Kennedy Sport Medicine Clinic
RECRUITING
London
Fraser Health Authority
RECRUITING
New Westminster
University of Ottawa
RECRUITING
Ottawa
St. Michael's Hospital
RECRUITING
Toronto
Pan Am Clinic
RECRUITING
Winnipeg
Denmark
Aarhus University Hospital
RECRUITING
Aarhus
Germany
Cologne-Merheim Medical Center, Klinik für Orthopädie, Unfallchirurgie und Sporttraumatologie
RECRUITING
Cologne
University Klinik Münster
RECRUITING
Münster
Ireland
Dublin City University / UPMC Sports Surgery Clinic
RECRUITING
Dublin
Norway
Oslo University Hospital
RECRUITING
Oslo
Sweden
Stockholm South Hospital, Karolinska Institutet
RECRUITING
Stockholm
United Kingdom
North Bristol Trust
RECRUITING
Bristol
University Hospitals Coventry and Warwickshire NHS Trust
RECRUITING
Coventry
Contact Information
Primary
Stacey Wanlin
swanlin@uwo.ca
519-661-2111
Time Frame
Start Date: 2020-07-28
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 1236
Treatments
Experimental: BPTB + LET
Patients will undergo anterior cruciate ligament reconstruction (ACLR) using a bone patellar bone tendon (BPTB) autograft with lateral extra-articular tenodesis (LET).
Active_comparator: BPTB alone
Patients will undergo ACLR using a BPTB autograft without LET.
Experimental: QT + LET
Patients will undergo ACLR using a quadriceps tendon (QT) autograft with LET.
Active_comparator: QT alone
Patients will undergo ACLR using a QT autograft without LET.
Related Therapeutic Areas
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), University of Western Ontario, Canada
Leads: University of Pittsburgh

This content was sourced from clinicaltrials.gov