Anterior Cruciate Ligament Rupture

Anterior Cruciate Ligament Rupture Clinical Trial

— LIGAMYS  

Official title:

Ligamys Technique Versus Standard Technique for the Anterior Cruciate Ligament Rupture

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02740452
• Other study ID #: CHU 0260
• Status: Recruiting
• Phase: N/A
• Start date: September 2016
• Est. completion date: June 2023

Study information

• Verified date: June 2021
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The assess results of Anterior Cruciate Ligament (ACL) repair with the Ligamys® surgical technique versus standard technique.

The aim of the study is to compare (laxity, instability, and safety) these two types of treatment by using a prospective, randomised multicenter analysis.

Description:

The treatment of acute ruptures of the anterior cruciate ligament is surgical in some cases with ligamentoplasty technique.

Contrary to the classic ligamentoplasty, the treatment with Ligamys consists of promoting heating of the ligament itself by controlling mechanical environment.

It allows a "dynamic" stabilization of the torn Anterior Cruciate Ligament with in the 3 weekly following traumatism. These techniques may improve the recovery process, proprioceptive results, decrease morbidity of transplant harvesting and faster for the patients. It's all these issues we would like to assess with a randomised multicenter study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Age between 18 to 35 years

• Primary Anterior Cruciate Ligament rupture

• signed patient consent

• surgery 21 days or less after traumatism for Ligamys technique

Exclusion Criteria:

• infection of the operating site

• previous osseous disease

• pregnant or nursing woman.

Related Conditions & MeSH terms

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

Intervention

Device:
• ligamys technique
Ligamys technique (device) or standard technique

Other:
• standard technique (anatomic reconstruction)
Ligamys technique (device) or standard technique

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Société Mathys SA for sponsoring Ligamys Device

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measuring anterior knee laxity with KT 1000 arthrometer		at 12 months
Secondary	Tegnér scores		at 12 months
Secondary	Lysholm scores		at 12 months
Secondary	IKDC score safety		at 12 months