Anterior Cruciate Ligament Rupture

Not Applicable

• Conditions: Anterior Cruciate Ligament Rupture
• Interventions: Device: ligamys technique; Other: standard technique (anatomic reconstruction)

• Registration Number: NCT02740452
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2016-03-25
• Study First Submitted QC: 2016-04-12
• Study First Posted: 2016-04-15
• Study Start: 2016-09
• Status Verified: 2021-06
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-15
• Primary Completion: 2022-12
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ligamys technique	ligamys technique	Ligamys technique (device) or standard technique
standard technique	standard technique (anatomic reconstruction)	Ligamys technique (device) or standard technique

Primary Outcome Measures

Name	Time	Method
Measuring anterior knee laxity with KT 1000 arthrometer	at 12 months

Secondary Outcome Measures

Name	Time	Method
Tegnér scores	at 12 months
Lysholm scores	at 12 months
IKDC score safety	at 12 months

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France