Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06147427

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de chirurgie orthopédique et de médecine du sport

Lyon, 69004, France

Location status: Recruiting

Location contact

Elvire SERVIEN, MD

CONTACT

[email protected]

4 26 10 92 98 ext. +33

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACL reconstruction with hamstrings combined with ALL plasty

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

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).

Primary outcomes

  1. Graft rupture rate

    Time frame: At 24 months post-operative

    Graft rupture rate (percentage)

Secondary outcomes

  1. International Knee Documentation Committee (IKDC) score

    Time frame: Pre-operatively and at 6, 12 and 24 months post-operatively

    Functional outcome : mean IKDC score

  2. Complications

    Time frame: Pre-operatively and at Day 0, Day 21, Day 45, 6 months, 12 months and 24 months post-operatively

    Complications all causes

Study contacts

Contact information is provided by the study sponsor or research team.

Elvire SERVIEN, MD

CONTACT

[email protected]

4 26 10 92 98 ext. +33

Mahé RAFFIN

CONTACT

[email protected]

426732738 ext. +33

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study 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

Acronym: ARAVET

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Nov 27, 2023
Registry last updated
Jan 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.