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

Not Applicable

Recruiting

• Conditions: Anterior Cruciate Ligament Injuries
• Interventions: Procedure: ACL reconstruction with hamstrings combined with modified Lemaire's LET; Procedure: ACL reconstruction with hamstrings combined with ALL plasty

• Registration Number: NCT06147427
• Lead Sponsor: Hospices Civils de Lyon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-17
• Study First Submitted QC: 2023-11-24
• Study First Posted: 2023-11-27
• Status Verified: 2024-01
• Study Start: 2024-01-16
• Last Update Submitted: 2024-01-16
• Last Update Posted: 2024-01-18
• Primary Completion: 2029-01-16
• Study Completion: 2029-01-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 248

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACL reconstruction with hamstrings combined with modified Lemaire's LET	ACL reconstruction with hamstrings combined with modified Lemaire's LET	Patient treated by ACL 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).
ACL reconstruction with hamstrings combined with ALL plasty	ACL reconstruction with hamstrings combined with ALL plasty	Patient treated by ACL 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).

Primary Outcome Measures

Name	Time	Method
Graft rupture rate	At 24 months post-operative	Graft rupture rate (percentage)

Secondary Outcome Measures

Name	Time	Method
International Knee Documentation Committee (IKDC) score	Pre-operatively and at 6, 12 and 24 months post-operatively	Functional outcome : mean IKDC score
Complications	Pre-operatively and at Day 0, Day 21, Day 45, 6 months, 12 months and 24 months post-operatively	Complications all causes

Trial Locations

Locations (1)

Service de chirurgie orthopédique et de médecine du sport; 🇫🇷 Lyon, France