Anterior Cruciate Ligament Rupture Clinical Trial
Official title:
Induced ACL Healing With the Ligamys Technique: a Prospective, Multicenter Observational Case Series
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.
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.
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