Clinical trial NCT06147427: ALL Reconstruction Versus Modified Lemaire's LET in Combination With ACL Reconstruction With a Minimum Follow up of 2 Years
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament Injuries
Keywords: ACL reconstruction
lateral extra-articular tenodesis
modified Lemaire tenodesis
anterolateral ligament
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-11-27
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Graft rupture rate
timeFrame: At 24 months post-operative
Secondary outcomes:
measure: International Knee Documentation Committee (IKDC) score
timeFrame: Pre-operatively and at 6, 12 and 24 months post-operatively
measure: Complications
timeFrame: Pre-operatively and at Day 0, Day 21, Day 45, 6 months, 12 months and 24 months post-operatively
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service de chirurgie orthopédique et de médecine du sport
Study officials:
affiliation: Service de chirurgie orthopédique et de médecine du sport
name: Elvire SERVIEN, MD
role: PRINCIPAL_INVESTIGATOR
References: