NCT02740452

Anterior Cruciate Ligament Rupture

Ligamys Technique Versus Standard Technique for the Anterior Cruciate Ligament Rupture

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anterior Cruciate Ligament Rupture

Interventions

Type	Name	Description
DEVICE	ligamys technique	Ligamys technique (device) or standard technique
OTHER	standard technique (anatomic reconstruction)	Ligamys technique (device) or standard technique

Timeline

• Start date: 2016-09-01
• Primary completion: 2022-12-01
• Completion: 2023-06-01
• First posted: 2016-04-15
• Last updated: 2022-03-15

Locations

1 site across 1 country: France