+1 877 705 191424 / 7
HIPAA Compliant
ISO 27001 Certified

Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
All Genders
ID06147427

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

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

Age: 18Years - 50Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Research Team

E

Elvire SERVIEN, MD

M

Mahé RAFFIN

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here