Anterior Cruciate Ligament Rupture (LIGAMYS)

University Hospital, Clermont-Ferrand

Status: Unknown

Conditions: Anterior Cruciate Ligament Rupture

Treatments: Other: standard technique (anatomic reconstruction); Device: ligamys technique

Study type: Interventional

Funder types: Other

Identifiers

NCT02740452

CHU 0260

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Ligamys technique

Other group

Description:

Ligamys technique (device) or standard technique

Treatment:

Device: ligamys technique

standard technique

Other group

Description:

Ligamys technique (device) or standard technique

Treatment:

Other: standard technique (anatomic reconstruction)