STABILITY 2: Anterior Cruciate Ligament Reconstruction +/- Lateral Tenodesis With Patellar vs Quad Tendon
Joint Instability | Anterior Cruciate Ligament Injury | ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTIONAnterior 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.
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
14 to 25
Participation 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.
Study Location
Fraser Health Authority
Fraser Health AuthorityNew Westminster, British Columbia
Canada
Contact Study Team
Kyrsten Payne, BSc.
(604) 553-3247Fowler Kennedy Sport Medicine Clinic
Fowler Kennedy Sport Medicine ClinicLondon, Ontario
Canada
Contact Study Team
University of Calgary Sport Medicine Centre
University of Calgary Sport Medicine CentreCalgary, Alberta
Canada
Contact Study Team
Denise Chan
McMaster University
McMaster UniversityHamilton, Ontario
Canada
Contact Study Team
Kestrel McNeill
Banff Sport Medicine Clinic
Banff Sport Medicine ClinicBanff, Alberta
Canada
Contact Study Team
Sarah Kerslake
403 760 2897Nova Scotia Health Authority
Nova Scotia Health AuthorityHalifax, Nova Scotia
Canada
Contact Study Team
Morgan King
St. Michael's Hospital
St. Michael's HospitalToronto, Ontario
Canada
Contact Study Team
Ryan Khan
Pan Am Clinic
Pan Am ClinicWinnipeg, Manitoba
Canada
Contact Study Team
Sheila McRae, PhD
204-925-7469University of Ottawa
University of OttawaOttawa, Ontario
Canada
Contact Study Team
Melanie Dodd-Moher
- Study Sponsored By
- University of Pittsburgh
- Participants Required
- More Information
- Study ID:
NCT03935750