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

Anterior Cruciate Ligament Injuries Clinical Trial

— ARAVET  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06147427
• Other study ID #: 69HCL23_0851
• Secondary ID: id-rcb
• Status: Recruiting
• Phase: N/A
• Start date: January 16, 2024
• Est. completion date: January 16, 2029

Study information

• Verified date: January 2024
• Source: Hospices Civils de Lyon
• Contact: Elvire SERVIEN, MD
• Phone: 4 26 10 92 98
• Email: elvire.servien[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 248
• Est. completion date: January 16, 2029
• Est. primary completion date: January 16, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries

Intervention

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).
• 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).

Locations

Country	Name	City	State
France	Service de chirurgie orthopédique et de médecine du sport	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Graft rupture rate	Graft rupture rate (percentage)	At 24 months post-operative
Secondary	International Knee Documentation Committee (IKDC) score	Functional outcome : mean IKDC score	Pre-operatively and at 6, 12 and 24 months post-operatively
Secondary	Complications	Complications all causes	Pre-operatively and at Day 0, Day 21, Day 45, 6 months, 12 months and 24 months post-operatively