Standard ACL Reconstruction vs ACL + Lateral Extra-Articular Tenodesis Study
Last updated on April 2022Recruitment
- Recruitment Status
- Unknown status
- Estimated Enrollment
- 600
Inclusion Criteria
- competitive pivoting sport
- generalized ligament laxity - Beighton score of 4 or greater
- skeletally mature to 25 years of age
- ...
- competitive pivoting sport
- generalized ligament laxity - Beighton score of 4 or greater
- skeletally mature to 25 years of age
- grade 2 pivot shift or greater
- ACL deficient knee
Exclusion Criteria
- previous ACL reconstruction on either knee
- symptomatic articular cartilage defect requiring treatment other than debridement
- multi-ligament injury (two or more ligaments requiring surgical attention)
- ...
- previous ACL reconstruction on either knee
- symptomatic articular cartilage defect requiring treatment other than debridement
- multi-ligament injury (two or more ligaments requiring surgical attention)
- unable to complete outcome questionnaires
- greater than 3 degrees of asymmetric varus
Summary
- Conditions
- Anterior Cruciate Ligament Reconstruction
- Type
- Interventional
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 14 years and 25 years
- Gender
- Both males and females
Description
This study is a pragmatic study for a parallel groups, randomized clinical trial in which 600 patients with anterior cruciate ligament insufficiency who are undergoing surgery, are randomly allocated to either ACL reconstruction alone (control) or ACL reconstruction with lateral extra-articular teno...
This study is a pragmatic study for a parallel groups, randomized clinical trial in which 600 patients with anterior cruciate ligament insufficiency who are undergoing surgery, are randomly allocated to either ACL reconstruction alone (control) or ACL reconstruction with lateral extra-articular tenodesis (experimental). Surgeons, data collectors, and the data analyst will be blind to group allocation. The primary outcome is rate of failure. Secondary outcomes include disease specific quality of life, return to function and sport. Patients are followed for two years postoperative.
Inclusion Criteria
- competitive pivoting sport
- generalized ligament laxity - Beighton score of 4 or greater
- skeletally mature to 25 years of age
- ...
- competitive pivoting sport
- generalized ligament laxity - Beighton score of 4 or greater
- skeletally mature to 25 years of age
- grade 2 pivot shift or greater
- ACL deficient knee
Exclusion Criteria
- previous ACL reconstruction on either knee
- symptomatic articular cartilage defect requiring treatment other than debridement
- multi-ligament injury (two or more ligaments requiring surgical attention)
- ...
- previous ACL reconstruction on either knee
- symptomatic articular cartilage defect requiring treatment other than debridement
- multi-ligament injury (two or more ligaments requiring surgical attention)
- unable to complete outcome questionnaires
- greater than 3 degrees of asymmetric varus
Tracking Information
- NCT #
- NCT02018354
- Collaborators
- International Society of Arthroscopy Knee Surgery and Orthopedic Sports Medicine
- Orthopedic Research and Education Foundation
- Investigators
- Principal Investigator: Alan Getgood, MD University of Western Ontario, Canada Study Director: Dianne Bryant, Phd University of Western Ontario, Canada
- Alan Getgood, MD University of Western Ontario, Canada Study Director: Dianne Bryant, Phd University of Western Ontario, Canada
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