Comparing two surgical techniques for ACL reconstruction
ARAVET : Antero-lateral Ligament Reconstruction Versus Modified Lemaire's Lateral Extra-articular Tenodesis in Combination With ACL Reconstruction With a Minimum Follow up of 2 Years: a Randomized Controlled Trial
This study is testing which of two surgical methods for ACL reconstruction works better for people with knee instability caused by additional ligament injuries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 248 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 1 site (Lyon) |
| Trial ID | NCT06147427 on ClinicalTrials.gov |
What this trial studies
This study compares two surgical techniques for reconstructing the anterior cruciate ligament (ACL) in patients with associated anterolateral ligament (ALL) injuries. The two approaches being evaluated are the modified Lemaire technique and a newer lateral extra-articular tenodesis (LET) method, both performed alongside ACL reconstruction using hamstring grafts. The study aims to determine which technique provides better stability and outcomes for patients with chronic knee instability. Participants will be followed for a minimum of two years to assess the effectiveness of each surgical method.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 to 50 with chronic anterior knee laxity and indications for anterolateral plasty, particularly those involved in pivot sports.
Not a fit: Patients with additional surgical procedures planned or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced rates of re-injury for patients undergoing ACL reconstruction.
How similar studies have performed: Previous studies have shown success with similar surgical techniques, but this specific comparison is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Man or woman with age between 18 and 50 years old * disabling anterior chronic laxity * 1 criteria of anterolateral plasty indication : pivot sport, rotatory instability with positive pivot shift test * Patient who signed the informed consent form. Exclusion Criteria: * any associated procedure (excluding meniscal resection or repair) like osteotomy or meniscus graft * pregnant patient * Persons deprived of their liberty by judicial or administrative decision, persons under psychiatric care * Adults under legal protection
Where this trial is running
Lyon
- Service de chirurgie orthopédique et de médecine du sport — Lyon, France (Recruiting)
Study contacts
- Principal investigator: Elvire SERVIEN, MD — Service de chirurgie orthopédique et de médecine du sport
- Study coordinator: Elvire SERVIEN, MD
- Email: elvire.servien@chu-lyon.fr
- Phone: 4 26 10 92 98
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.