ACL Versus ALL + ACL Study

Ascopharm Groupe Novasco

Status: Completed

Conditions: Ligament Rupture; Anterior Cruciate Ligament Injury

Treatments: Procedure: ACL + ALL plasty; Procedure: ACL plasty

Study type: Interventional

Funder types: Other

Identifiers

NCT03740022

2016-A00144-47

Details and patient eligibility

About

The aim of the study is to show a reduction of a re-rupture rate with an ACL (antero crusader ligament) + ALL (anterolateral ligament) combined technique compared to a classical Kenneth-Jones ACL (antero crusader ligament) reconstruction technique.

Full description

The aim is to evaluate the rate of re-rupture and to analyze knee function through scores analysis as International Knee Documentation Committee Subjective Knee (IKDC), Knee injury and osteoarthritis outcome score (KOOS), Lysholm-Tegner, and by objective measurements of laximetry and rotation.

This study should include 2 groups of 296 patients with isolated ACL (antero crusader ligament) with clinical rotation :

• operated by a conventional patellar tendon technique (first group)
• operated by a technique combining a ALL (anterolateral ligament) and ACL plasty for the second group

Enrollment: 592 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with total isolated antero crusader ligament (ACL) rupture who are candidates for surgical reconstruction
• Patients between 18 and 35 years old
• Patients with weekly sporting activities
• Patients with chronic rotatory instability with a positive pivot shift
• Patients who have been informed and do not object the research

Exclusion criteria

• Patients with multi-ligament knee involvement
• Patients under 18 years old or over 35 years old
• Patients with a BMI of under 18.5 or over 30
• Patients with any contraindication to general anaesthesia
• Professional sportsmen/women
• Patients with congenital malformation or a rheumatic disease
• Patients with repeated antero crusader ligament (ACL) rupture
• Patients with serious ligament disease in the contralateral knee
• Patients who refuse to take part in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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592 participants in 2 patient groups

ACL plasty

Active Comparator group

Description:

The surgical procedure consists of a ligamentoplasty of the antero crusader ligament (ACL) with the patellar tendon according to a conventional arthroscopic procedure.

Treatment:

Procedure: ACL plasty

ACL + ALL plasty

Experimental group

Description:

The surgical procedure consists of a hamstring ligamentoplasty (DIDT) of the antero crusader ligament (ACL) and anterolateral ligament (ALL) according to a published arthroscopic procedure.

Treatment:

Procedure: ACL + ALL plasty