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Procedure
ACL Reconstruction vs ACL + LET for ACL Tear (STAbiLiTY Trial)
N/A
Waitlist Available
Led By Alan Getgood, MD
Research Sponsored by University of Western Ontario, Canada
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
skeletally mature to 25 years of age
grade 2 pivot shift or greater
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3, 6, 12, 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is comparing two types of surgeries for patients with a knee injury called anterior cruciate ligament (ACL) tear. One surgery is the usual ACL reconstructive surgery, and the other surgery includes
Who is the study for?
This trial is for individuals aged up to 25 with an ACL deficient knee who play competitive pivoting sports. They must have a significant pivot shift in the knee (grade 2 or higher) and some general ligament looseness, as indicated by a Beighton score of at least 4.
What is being tested?
The study compares usual ACL reconstructive surgery against ACL reconstruction combined with lateral extra-articular tenodesis (LET), which adds extra tendon repair outside the knee, to see if it better prevents graft failure.
What are the potential side effects?
Potential side effects may include pain at the surgery site, swelling, stiffness in the knee joint, weakness or loss of strength in surrounding muscles, and complications related to graft failure or healing.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between the ages when bones stop growing and 25 years old.
Select...
My knee is unstable when it rotates.
Select...
My knee lacks a functioning ACL.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3, 6, 12, 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3, 6, 12, 24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Graft Failure
Secondary study objectives
Disease-specific quality of life using the ACL Quality of Life Questionnaire (ACL-QOL)
MARX Activity Rating Scale
Passive knee extension and active-assisted knee flexion
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ACL + LETExperimental Treatment2 Interventions
Anatomic ACL reconstruction following the same procedure as the active comparator group with an added lateral extra-articular tenodesis (LET).
Group II: ACL ReconstructionActive Control1 Intervention
Standard ACL reconstruction only.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ACL Reconstruction
2016
N/A
~20
Find a Location
Who is running the clinical trial?
Orthopedic Research and Education FoundationOTHER
20 Previous Clinical Trials
5,046 Total Patients Enrolled
University of Western Ontario, CanadaLead Sponsor
166 Previous Clinical Trials
318,734 Total Patients Enrolled
1 Trials studying Anterior Cruciate Ligament Reconstruction
1,236 Patients Enrolled for Anterior Cruciate Ligament Reconstruction
International Society of Arthroscopy Knee Surgery and Orthopedic Sports MedicineUNKNOWN
Alan Getgood, MDPrincipal InvestigatorUniversity of Western Ontario, Canada
Dianne Bryant, PhdStudy DirectorUniversity of Western Ontario, Canada