ACL Versus ALL + ACL Study

Not Applicable

Completed

• Conditions: Anterior Cruciate Ligament Injury; Ligament Rupture
• Interventions: Procedure: ACL plasty; Procedure: ACL + ALL plasty

• Registration Number: NCT03740022
• Lead Sponsor: Ascopharm Groupe Novasco

Brief Summary

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.

Detailed 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

Study Timeline

• Study Start: 2016-11-02
• Study First Submitted: 2016-11-29
• Study First Submitted QC: 2018-11-09
• Study First Posted: 2018-11-14
• Primary Completion: 2024-06-10
• Study Completion: 2024-06-10
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 592

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACL plasty	ACL plasty	The surgical procedure consists of a ligamentoplasty of the antero crusader ligament (ACL) with the patellar tendon according to a conventional arthroscopic procedure.
ACL + ALL plasty	ACL + ALL plasty	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.

Primary Outcome Measures

Name	Time	Method
Ligament re-rupture rate	3 years	Clinical instability, laximetry, IRM

Secondary Outcome Measures

Name	Time	Method
International Knee Documentation Committee Subjective Knee (IKDC) clinical score	preoperatively, 1 year and 3 years	International Knee Documentation Committee Subjective Knee allows a subjective assessment including symptoms, activity and knee function; is scored by summing the scores for the individual items and then transforming the score to a scale that ranges from 0 to 100 (no limitation with activities of daily living or sports activities and the absence of symptoms)
Tegner Lysholm score	Preoperatively, 1 year and 3 years	Specific knee questionnaire : patient-reported instrument that consists of subscales for pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. Scores range from 0 (worse disability) to 100 (less disability).
Knee injury and osteoarthritis outcome score (KOOS) clinical score	preoperative, 1 year and 3 years	Knee injury and osteoarthritis outcome score is a specific knee questionnaire which evaluates : pain, symptoms, knee function in daily life, knee function in sport practice and quality of life. Scale : None (0) Mild Moderate Severe Extreme (4) Each subscale score is calculated independently. Calculate the mean score of the individual items of each subscale and divide by 4. Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems
Rolimeter test	pre-operatively, 6 months, 1 year and 3 years	Antero-posterior laximetry
KiRA test	preoperatively, 6 months and 3 years	Rotatory laximetry
Knee radiography	preoperatively and 3 years	Development of osteoarthritis signs

Trial Locations

Locations (1)

Hôpital Privé Jean Mermoz - Centre Paul Santy; 🇫🇷 Lyon, France