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Recruiting young active ACL-deficient patients at high risk of ACL re-injury

ACL Tear (Anterior Cruciate Ligament)

Anterior cruciate ligament (ACL) reconstruction surgery has unacceptably high failure rates in young active individuals. ACL graft choice and/or augmentation with a lateral extra-articular tenodesis (LET) has the potential to reduce failure rates in this patient population.
This international, multicentre randomized clinical trial will determine if ACLR using a patient’s own quadriceps tendon or patellar tendon, either with or without a LET, reduces the risk of ACL failure, results in less symptoms, better function and quality of life, and an improved ability to return to sports. It is anticipated that 1,234 people will participate from research sites in Canada, the United States, Germany, Norway, the United Kingdom and Sweden.

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Participation Requirements

  • Sex:

    Male, Female, Intersex

  • Eligible Ages:

    14 to 25

Participation Criteria

Inclusion Criteria:
Patients meeting the following INCLUSION CRITERIA may be eligible for the study:
1) ACL-deficient knee
2) Ages 14 – 25 years
3) Skeletally mature
4) Two of the following:
- Competes in a competitive pivoting sport
- Has generalized ligamentous laxity (> 4 Beighton score)
- Grade 2 pivot shift
- Genu recurvatum of >10 degrees

Exclusion Criteria:
Patients with the following EXCLUSION CRITERIA are not eligible for the study:
1) Previous ACL reconstruction of either knee
2) Multiple ligament injury (ie: PCL, collaterals) requiring repair / reconstruction
3) Symptomatic articular cartilage defect
4) Inflammatory arthritis, metabolic bone, collagen, crystalline, degenerative joint or neoplastic disease
5) Femoral, tibial or patellar fracture (other than Segond fractures)
6) Asymmetric valgus or varus > 3 degrees
7) Debilitating anterior knee pain, patellar or quadriceps tendon tendonitis

Study Location

University of Calgary
University of Calgary
Calgary, Alberta
Canada

Contact Study Team

Study Sponsored By
University of Calgary
Participants Required
More Information
Study ID: REB19-0781