NCT02203214

Induced ACL Healing With the Ligamys Technique: a Prospective, Multicenter Observational Case Series

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 110 (actual)
• Sponsor: Mathys Ltd Bettlach · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and effectiveness of the Ligamys technique for the treatment of acute ruptures of the anterior cruciate ligament in a multicenter routine clinical setting. To conduct a long-term follow-up of the case series as a post-market product surveillance endeavor.

Detailed description

The Ligamys method was successfully applied in an animal study including eleven white alpine sheep. Healing of the torn ACL and a stable joint without signs of intra-articular damages or osteoarthritis three months postoperative were observed (Kohl KSSTA 2013). In a first clinical study with ten patients, the Ligamys surgical technique resulted in stable clinical and radiological healing of the torn ACL in nine patients with one re-rupture after four months. Nine patients obtained normal knee scores, reported excellent patient satisfaction, and could return to their previous levels of sporting activity (Kohl Swiss Med Wkly 2011). The purpose of this study is to evaluate the safety and effectiveness of the Ligamys technique for the treatment of acute ruptures of the anterior cruciate ligament in a multicenter routine clinical setting. To conduct a long-term follow-up of the case series as a post-market product surveillance endeavor.

Conditions

• Anterior Cruciate Ligament Rupture

Interventions

Type	Name	Description
DEVICE	Ligamys	All patients are treated with Ligamys within 21 days after injury. The Ligamys implant has to be used in accordance with the instructions for use.

Timeline

• Start date: 2013-08-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2014-07-29
• Last updated: 2018-08-17

Locations

3 sites across 3 countries: Belgium, Germany, Switzerland