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

NCT ID: NCT06147427

Last Updated: 2024-01-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 248 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-16
• Study Completion Date: 2029-01-16

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.

Conditions

Anterior Cruciate Ligament Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

ACL reconstruction with hamstrings combined with ALL plasty

Intervention Type: PROCEDURE

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).

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).

Group Type: EXPERIMENTAL

ACL reconstruction with hamstrings combined with modified Lemaire's LET

Intervention Type: PROCEDURE

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).

Interventions

ACL reconstruction with hamstrings combined with ALL plasty

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).

Intervention Type: PROCEDURE

ACL reconstruction with hamstrings combined with modified Lemaire's LET

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).

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elvire SERVIEN, MD

Role: PRINCIPAL_INVESTIGATOR

Service de chirurgie orthopédique et de médecine du sport

Locations

Service de chirurgie orthopédique et de médecine du sport

Lyon, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Elvire SERVIEN, MD

Role: CONTACT

elvire.servien@chu-lyon.fr

4 26 10 92 98 ext. +33

Mahé RAFFIN

Role: CONTACT

mahe.raffin@chu-lyon.fr

426732738 ext. +33

Facility Contacts

Elvire SERVIEN, MD

Role: primary

elvire.servien@chu-lyon.fr

4 26 10 92 98 ext. +33

Other Identifiers

id-rcb

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL23_0851

Identifier Type: -

Identifier Source: org_study_id