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Trials / Recruiting

RecruitingNCT06147427

ALL Reconstruction Versus Modified Lemaire's LET in Combination With ACL Reconstruction With a Minimum Follow up of 2 Years

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
248 (estimated)
Sponsor
Hospices Civils de Lyon · Academic / Other
Sex
All
Age
18 Years – 50 Years
Healthy volunteers
Not accepted

Summary

Anterior cruciate ligament (ACL) tears are associated with concomitant lesions of the anterolateral ligament (ALL), which increase rotatory instability of the knee. If untreated, ALL insufficiency can compromise the results of ACL reconstruction, with higher risk of iterative ACL tear or additional meniscal lesion. Several surgical techniques have been described to reconstruct the ALL. Indications are increasingly frequent and actually, consensus being young patients, patients practising pivot sports, significant rotational laxity on clinical examination with a positive pivot shift test, or in cases of iterative surgery. To date, the two most popular techniques are the Lemaire technique (use of a fascia lata strip) and LAL reconstruction plasty (use of part of an accessory hamstring tendon). The older Lemaire procedure, popularized in the 1980s has proved its efficiency in terms of biomechanics, safety and reproducibility. More recently, following a new, precise anatomical description, anterolateral ligament plasty (ALL) has been developed, which is intended to be more anatomical than Lemaire's technique, but whose clinical superiority has not yet been demonstrated. Both techniques are currently used in our department, with the choice of technique left to the surgeon's discretion. To date, no randomized prospective study has demonstrated the clinical superiority of one technique over the other with a long term follow up. The aim of this study was to compare graft survival of ALL reconstruction versus modified Lemaire LET in combination with ACL reconstruction with a minimum follow up of 2 years. Secondary aim was to compare functional outcomes between both groups.

Conditions

Interventions

TypeNameDescription
PROCEDUREACL reconstruction with hamstrings combined with ALL plastyACL reconstruction with hamstrings combined anterolateral plasty using the ALL reconstruction technique (Gracilis throught the femur tunnel of the ACL graft and fixed to the tibia by an anchor on its point of isometry on the tibia).
PROCEDUREACL reconstruction with hamstrings combined with modified Lemaire's LETACL reconstruction with hamstrings combined with modified Lemaire's lateral extra-articular tenodesis technique (Fascia lata strip pedicled to the Gerdy and fixed to the femur throught the tunnel of the ACL graft).

Timeline

Start date
2024-01-16
Primary completion
2029-01-16
Completion
2029-01-16
First posted
2023-11-27
Last updated
2024-01-18

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT06147427. Inclusion in this directory is not an endorsement.