Recruitment

Recruitment Status
Unknown status
Estimated Enrollment
600

Inclusion Criteria

generalized ligament laxity - Beighton score of 4 or greater
grade 2 pivot shift or greater
competitive pivoting sport
...
generalized ligament laxity - Beighton score of 4 or greater
grade 2 pivot shift or greater
competitive pivoting sport
skeletally mature to 25 years of age
ACL deficient knee

Exclusion Criteria

multi-ligament injury (two or more ligaments requiring surgical attention)
symptomatic articular cartilage defect requiring treatment other than debridement
unable to complete outcome questionnaires
...
multi-ligament injury (two or more ligaments requiring surgical attention)
symptomatic articular cartilage defect requiring treatment other than debridement
unable to complete outcome questionnaires
previous ACL reconstruction on either knee
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

generalized ligament laxity - Beighton score of 4 or greater
grade 2 pivot shift or greater
competitive pivoting sport
...
generalized ligament laxity - Beighton score of 4 or greater
grade 2 pivot shift or greater
competitive pivoting sport
skeletally mature to 25 years of age
ACL deficient knee

Exclusion Criteria

multi-ligament injury (two or more ligaments requiring surgical attention)
symptomatic articular cartilage defect requiring treatment other than debridement
unable to complete outcome questionnaires
...
multi-ligament injury (two or more ligaments requiring surgical attention)
symptomatic articular cartilage defect requiring treatment other than debridement
unable to complete outcome questionnaires
previous ACL reconstruction on either knee
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