Actively Recruiting
Antero-lateral Ligament Reconstruction Versus Modified Lemaire's Lateral Extra-articular Tenodesis With ACL Reconstruction With a Minimum 2-Year Follow-Up: A Randomized Controlled Trial
Led by Hospices Civils de Lyon · Updated on 2024-01-18
248
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating two surgical techniques used alongside anterior cruciate ligament (ACL) reconstruction to address injuries involving the anterolateral ligament (ALL), which can increase knee instability. The study aims to compare the long-term graft survival and functional outcomes of the ALL reconstruction technique versus the modified Lemaire lateral extra-articular tenodesis (LET) technique over a minimum follow-up of two years. This trial responds to the need for evidence on which technique may provide better results for patients with ACL injuries who have risk factors such as participation in pivot sports and significant rotational knee laxity. Participants will receive ACL reconstruction with hamstring tendons combined with either the ALL reconstruction technique, which uses a gracilis tendon through the femur tunnel of the ACL graft fixed to the tibia, or the modified Lemaire LET technique, which uses a fascia lata strip attached near the knee and fixed through the femur tunnel of the ACL graft. The choice of technique is assigned randomly to compare these two approaches directly. Both procedures are performed during surgery to provide additional knee stability. During the study, participants will be monitored for graft rupture rates at 24 months after surgery, which is the main outcome measure. Additional assessments include the International Knee Documentation Committee (IKDC) score before surgery and at 6, 12, and 24 months afterward, as well as tracking any complications at multiple timepoints including immediately post-operation and during follow-up visits. The study lasts at least two years with regular evaluations to measure knee function and safety of the procedures.
CONDITIONS
Brief Title
ALL Reconstruction Versus Modified Lemaire's LET in Combination With ACL Reconstruction With a Minimum Follow up of 2 Years
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Man or woman aged between 18 and 50 years old
- Disabling anterior chronic knee laxity
- At least one indication for anterolateral plasty such as participation in pivot sports or positive pivot shift test
- Signed informed consent form
You will not qualify if you...
- Any associated procedure besides meniscal resection or repair, such as osteotomy or meniscus graft
- Pregnant patients
- Persons deprived of liberty by judicial or administrative decision or under psychiatric care
- Adults under legal protection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 0 to Day 45 post-operative
Participants undergo ACL reconstruction combined with either ALL plasty or modified Lemaire's LET and receive immediate post-operative care.
3 visits (Day 0, Day 21, Day 45)
Duration - Up to 24 months post-operative
Participants are monitored for recovery and complications and complete assessments of knee function up to 24 months after surgery.
Visits at 6 months, 12 months, and 24 months post-operative
Trial Site Locations
Total: 1 location
1
Service de chirurgie orthopédique et de médecine du sport
Lyon, France, 69004
Actively Recruiting
Research Team
E
Elvire SERVIEN, MD
M
Mahé RAFFIN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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