ACL Versus ALL + ACL Study

Anterior Cruciate Ligament Injury Clinical Trial

Official title:

Assessment of the Results of Combined Anterolateral Ligament (ALL) + Antero Crusader Ligament (ACL) Plasty Compared to Classical KJ Plasty in Isolated ACL Ruptures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03740022
• Other study ID #: 2016-A00144-47
• Status: Recruiting
• Phase: N/A
• Start date: November 2016
• Est. completion date: August 2022

Study information

• Verified date: April 2019
• Source: Ascopharm Groupe Novasco
• Contact: SONNERY-COTTET Bertrand, Dr
• Phone: +33 4 37 53 00 22
• Email: sonnerycottet[@]aol.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 592
• Est. completion date: August 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Injury
• Ligament Rupture
• Rupture

Intervention

Procedure:
• ACL plasty
standard ligamentoplasty by Kenneth Jones
• ACL + ALL plasty
standard ligamentoplasty and anterolateral plasty

Locations

Country	Name	City	State
France	Hôpital Privé Jean Mermoz - Centre Paul Santy	Lyon

Sponsors (2)

Lead Sponsor	Collaborator
Ascopharm Groupe Novasco	Ramsay Générale de Santé

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ligament re-rupture rate	Clinical instability, laximetry, IRM	3 years
Secondary	International Knee Documentation Committee Subjective Knee (IKDC) clinical score	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)	preoperatively, 1 year and 3 years
Secondary	Tegner Lysholm score	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).	Preoperatively, 1 year and 3 years
Secondary	Rolimeter test	Antero-posterior laximetry	pre-operatively, 6 months, 1 year and 3 years
Secondary	KiRA test	Rotatory laximetry	preoperatively, 6 months and 3 years
Secondary	Knee radiography	Development of osteoarthritis signs	preoperatively and 3 years
Secondary	Knee injury and osteoarthritis outcome score (KOOS) clinical score	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	preoperative, 1 year and 3 years