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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06147427
Acronym
ARAVET
Enrollment
248
Registered
2023-11-27
Start date
2024-01-16
Completion date
2029-01-16
Last updated
2024-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Injuries

Keywords

ACL reconstruction, lateral extra-articular tenodesis, modified Lemaire tenodesis, anterolateral ligament

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.

Interventions

PROCEDUREACL 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).

PROCEDUREACL 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).

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Graft rupture rateAt 24 months post-operativeGraft rupture rate (percentage)

Secondary

MeasureTime frameDescription
International Knee Documentation Committee (IKDC) scorePre-operatively and at 6, 12 and 24 months post-operativelyFunctional outcome : mean IKDC score
ComplicationsPre-operatively and at Day 0, Day 21, Day 45, 6 months, 12 months and 24 months post-operativelyComplications all causes

Countries

France

Contacts

Primary ContactElvire SERVIEN, MD
elvire.servien@chu-lyon.fr4 26 10 92 98
Backup ContactMahé RAFFIN
mahe.raffin@chu-lyon.fr426732738

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026