Soft Tissue Regeneration, Inc, has announced its completed enrollment for a clinical trial of the company’s L-C Ligament, which is a bioresorbable scaffold for soft tissue regeneration of the anterior cruciate ligament (ACL) of the knee. The clinical trial is a multi-center, non-randomized trial that aims to evaluate the safety profile of the L-C Ligament in 15 males and females with acute ACL injuries. The trial is being conducted at Isala Klinieken in Zwolle, The Netherlands, by Kees van Egmond, MD, and at Martini Hospital in Groningen, The Netherlands by Reinoud Brouwer, MD.
A larger, randomized clinical trial in Europe is anticipated to begin in September. According to a Soft Tissue Regeneration news release, the outcome by which the effectiveness of treatments is evaluated in this study is the rate of revision surgery in treated patients. The multi-center trial will also measure the patient’s clinical, radiographic, and subjective outcomes. The L-C Ligament is a synthetic bioresorbable scaffold that is designed to stabilize the knee after ACL reconstruction surgery.
The Soft Tissue Regeneration news release notes the L-C Ligament is anticipated to encourage the regeneration of the patient’s own ligament tissue. The device is investigational and is presently not available for use or sale in the United States or the European Union. Dr. van Egmon says, “This procedure has the potential to facilitate faster, improved healing with very little surgical morbidity for patient.”
Joseph Reilly, president and CEO of Soft Tissue Regeneration, says, “The first patient was implanted on June 18, 2013, and is now out more than 10 months. All 15 patients are doing extremely well and are following a normal course of physical rehabilitation. This is the first step in a process that will help improve patient outcomes on so many levels.”
Source: Soft Tissue Regeneration, Inc