ALL Reconstruction Versus Modified Lemaire's LET in Combination With ACL Reconstruction With a Minimum Follow up of 2 Years
ARAVET
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
2 other identifiers
interventional
248
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2023
CompletedFirst Posted
Study publicly available on registry
November 27, 2023
CompletedStudy Start
First participant enrolled
January 16, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 16, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 16, 2029
January 18, 2024
January 1, 2024
5 years
November 17, 2023
January 16, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Graft rupture rate
Graft rupture rate (percentage)
At 24 months post-operative
Secondary Outcomes (2)
International Knee Documentation Committee (IKDC) score
Pre-operatively and at 6, 12 and 24 months post-operatively
Complications
Pre-operatively and at Day 0, Day 21, Day 45, 6 months, 12 months and 24 months post-operatively
Study Arms (2)
ACL reconstruction with hamstrings combined with ALL plasty
EXPERIMENTALPatient 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).
ACL reconstruction with hamstrings combined with modified Lemaire's LET
EXPERIMENTALPatient 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).
Interventions
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 lateral extra-articular tenodesis technique (Fascia lata strip pedicled to the Gerdy and fixed to the femur throught the tunnel of the ACL graft).
Eligibility Criteria
You may qualify if:
- Man or woman with age between 18 and 50 years old
- disabling anterior chronic laxity
- criteria of anterolateral plasty indication : pivot sport, rotatory instability with positive pivot shift test
- Patient who signed the informed consent form.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Service de chirurgie orthopédique et de médecine du sport
Lyon, 69004, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elvire SERVIEN, MD
Service de chirurgie orthopédique et de médecine du sport
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2023
First Posted
November 27, 2023
Study Start
January 16, 2024
Primary Completion (Estimated)
January 16, 2029
Study Completion (Estimated)
January 16, 2029
Last Updated
January 18, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share