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

January 16, 2024 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

248

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Lyon, France, 69004
        • Recruiting
        • Service de chirurgie orthopédique et de médecine du sport
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Procedure: 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).
Experimental: 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).
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Graft rupture rate
Time Frame: At 24 months post-operative
Graft rupture rate (percentage)
At 24 months post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Knee Documentation Committee (IKDC) score
Time Frame: Pre-operatively and at 6, 12 and 24 months post-operatively
Functional outcome : mean IKDC score
Pre-operatively and at 6, 12 and 24 months post-operatively
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
Pre-operatively and at Day 0, Day 21, Day 45, 6 months, 12 months and 24 months post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Elvire SERVIEN, MD, Service de chirurgie orthopédique et de médecine du sport

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2024

Primary Completion (Estimated)

January 16, 2029

Study Completion (Estimated)

January 16, 2029

Study Registration Dates

First Submitted

November 17, 2023

First Submitted That Met QC Criteria

November 24, 2023

First Posted (Actual)

November 27, 2023

Study Record Updates

Last Update Posted (Estimated)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 16, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL23_0851
  • ID-RCB (Other Identifier: 2023-A01756-39)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anterior Cruciate Ligament Injuries

Clinical Trials on ACL reconstruction with hamstrings combined with ALL plasty

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe