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Comparing Anterolateral Ligament Reconstruction and Modified Lemaires Lateral Extra-articular Tenodesis with ACL Reconstruction over 2 Years
Led by Hospices Civils de Lyon · Updated on 2024-01-18
248
Participants Needed
1
Research Sites
N/A
Total Duration
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
Research Team
E
Elvire SERVIEN, MD
M
Mahé RAFFIN
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