STABILITY 2: Anterior Cruciate Ligament Reconstruction +/- Lateral Tenodesis With Patellar vs Quad Tendon
STABILITY 2
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)
2 other identifiers
interventional
1,236
8 countries
31
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2020
Longer than P75 for not_applicable
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2019
CompletedFirst Posted
Study publicly available on registry
May 2, 2019
CompletedStudy Start
First participant enrolled
July 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
April 14, 2026
April 1, 2026
6.9 years
March 25, 2019
April 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ACL Clinical Failure
This is a composite endpoint defined as 1) graft rupture or, 2) persistent rotational laxity (asymmetrical positive pivot shift).
24 months
Secondary Outcomes (14)
ACL-Quality of Life (QOL) Questionnaire
24 months (at 1.5, 3, 6, 12 and 24 months)
Knee injury and Osteoarthritis Outcome Score (KOOS)
24 months (at 1.5, 3, 6, 12 and 24 months)
International Knee Documentation Committee Subjective Knee Form (IKDC-SKF)
24 months (at 1.5, 3, 6, 12 and 24 months)
Marx Activity Rating Scale
24 months (at 1.5, 3, 6, 12 and 24 months)
Side-to-side difference in knee range of motion
24 months (at 1.5, 3, 6, 12 and 24 months)
- +9 more secondary outcomes
Study Arms (4)
BPTB + LET
EXPERIMENTALPatients will undergo anterior cruciate ligament reconstruction (ACLR) using a bone patellar bone tendon (BPTB) autograft with lateral extra-articular tenodesis (LET).
BPTB alone
ACTIVE COMPARATORPatients will undergo ACLR using a BPTB autograft without LET.
QT + LET
EXPERIMENTALPatients will undergo ACLR using a quadriceps tendon (QT) autograft with LET.
QT alone
ACTIVE COMPARATORPatients will undergo ACLR using a QT autograft without LET.
Interventions
Participants randomized to the BPTB or QT arms will be randomized a second time to a LET procedure or no additional surgery.
All participants will undergo an anatomic ACLR with either a BPTB or QT autograft, as randomized.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Stanford University
Redwood City, California, 94063, United States
University of California, San Francisco
San Francisco, California, 94158, United States
Orlando Health Jewett Orthopedic Institute
Orlando, Florida, 32806, United States
Med Center Health
Bowling Green, Kentucky, 42101, United States
University of Kentucky
Lexington, Kentucky, 40504, United States
Ochsner Clinic Foundation
Baton Rouge, Louisiana, 70836, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
University of New Mexico
Albuquerque, New Mexico, 87131, United States
Hospital for Special Surgery
New York, New York, 10021, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27101, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260, United States
The Rector and Visitors of the University of Virginia
Charlottesville, Virginia, 22903, United States
Banff Sport Medicine Clinic
Banff, Alberta, T1L 1B3, Canada
University of Calgary Sport Medicine Centre
Calgary, Alberta, T2N 1N4, Canada
Fraser Health Authority
New Westminster, British Columbia, V3L 5P5, Canada
Pan Am Clinic
Winnipeg, Manitoba, R3M 3E4, Canada
Nova Scotia Health Authority
Halifax, Nova Scotia, B3H 3A6, Canada
McMaster University
Hamilton, Ontario, L8N 3Z5, Canada
Fowler Kennedy Sport Medicine Clinic
London, Ontario, N6A 3K7, Canada
University of Ottawa
Ottawa, Ontario, K1N 6N5, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Aarhus University Hospital
Aarhus, Denmark
Cologne-Merheim Medical Center, Klinik für Orthopädie, Unfallchirurgie und Sporttraumatologie
Cologne, 51109, Germany
University Klinik Münster
Münster, 48149, Germany
Dublin City University / UPMC Sports Surgery Clinic
Dublin, Dublin 9, D09 C523, Ireland
Oslo University Hospital
Oslo, 0372, Norway
Stockholm South Hospital, Karolinska Institutet
Stockholm, 922M+CC, Sweden
North Bristol Trust
Bristol, BS10 5NB, United Kingdom
University Hospitals Coventry and Warwickshire NHS Trust
Coventry, CV2 2DX, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James J Irrgang, PT PhD FAPTA
University of Pittsburgh
- PRINCIPAL INVESTIGATOR
Alan Getgood, MD FRCS
Fowler Kennedy Sport Medicine Clinic, Western University, Department of Surgery
- PRINCIPAL INVESTIGATOR
Volker Musahl, MD
University of Pittsburgh
- PRINCIPAL INVESTIGATOR
Dianne M Bryant, PhD
Western University, School of Physical Therapy & Department of Surgery
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- All outcome assessors will be blinded to group allocation.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 25, 2019
First Posted
May 2, 2019
Study Start
July 28, 2020
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2028
Last Updated
April 14, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- The public-use version of the database will be made available two years after the study's main paper is published.
- Access Criteria
- Outside investigators wishing to conduct analyses using the data will submit a request with objectives, methods, and analysis plan to the PI and the Director of the DCC. Once the request is approved, the public-use version of the dataset, with documentation, will be sent by secure email using e-mail, ftp, or other mutually agreeable transmission method.
A public-use version of the dataset will be constructed by the Data Coordinating Center (DCC) with contents to be determined jointly by the study PIs and the DCC Director. Copies of the public-use version of the dataset will be housed at the DCC on the DA secure server along with suitable documentation of this dataset. The public-use version of the dataset will be exported by CRF in one or more files in simple, widely-accessible formats, e.g., .xls, .csv, and/or SAS datasets. Documentation will be in .pdf files.