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STABILITY 2: Anterior Cruciate Ligament Reconstruction +/- Lateral Tenodesis With Patellar vs Quad Tendon

Joint Instability | Anterior Cruciate Ligament Injury | ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION

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.

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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 Authority
New Westminster, British Columbia
Canada

Contact Study Team

Primary Contact

Kyrsten Payne, BSc.

(604) 553-3247
Fowler Kennedy Sport Medicine Clinic
Fowler Kennedy Sport Medicine Clinic
London, Ontario
Canada

Contact Study Team

Primary Contact

Stacey Wanlin

[email protected]
519-661-2111
University of Calgary Sport Medicine Centre
University of Calgary Sport Medicine Centre
Calgary, Alberta
Canada

Contact Study Team

Primary Contact

Denise Chan

McMaster University
McMaster University
Hamilton, Ontario
Canada

Contact Study Team

Primary Contact

Kestrel McNeill

Banff Sport Medicine Clinic
Banff Sport Medicine Clinic
Banff, Alberta
Canada

Contact Study Team

Primary Contact

Sarah Kerslake

403 760 2897
Nova Scotia Health Authority
Nova Scotia Health Authority
Halifax, Nova Scotia
Canada

Contact Study Team

Primary Contact

Morgan King

St. Michael's Hospital
St. Michael's Hospital
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Ryan Khan

Pan Am Clinic
Pan Am Clinic
Winnipeg, Manitoba
Canada

Contact Study Team

Primary Contact

Sheila McRae, PhD

204-925-7469
University of Ottawa
University of Ottawa
Ottawa, Ontario
Canada

Contact Study Team

Primary Contact

Melanie Dodd-Moher

Study Sponsored By
University of Pittsburgh
Participants Required
More Information
Study ID: NCT03935750