A medical device company called Soft Tissue Regeneration, Inc. has completed enrollment for a clinical trial of the company’s L-C Ligament, a bioresorbable scaffold for soft tissue regeneration of the anterior cruciate ligament (ACL) of the knee.
Trial Tests Regeneration of ACL Tissue
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The clinical trial is a prospective, multi-center test to evaluate the safety profile of the L-C Ligament in 15 males and females with acute ACL injuries. The effectiveness of the treatments will be judged by the rate of revision surgery in the treated patients, as well as their radiographic, clinical and subjective outcomes.
“The first patient was implanted on June 18, 2013, and is now out more than 10 months, ” said Joseph Reilly, president and CEO of Soft Tissue Regeneration. “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 many levels.
Reilly described L-C Ligament as being a synthetic bioresorbable scaffold that is designed to stabilize the knee after ACL reconstruction surgery. It is a patented technology that uses a clinically-proven polymer called poly(L-lactic acid) (PLLA) that is widely used in orthopedic implantable devices. He said that it addresses known risks and morbidity associated with allograft and auto graft tissues.
“This procedure is straight forward, fast and does not require harvesting of the patient’s tendon, thereby eliminating the risks associated with the harvest site”, said Kees van Egmond, M.D., who is the first surgeon in the world to implant the L-C Ligament. “This procedure has the potential to facilitate faster, improved healing with very little surgical morbidity for patients.
The L-C Ligament is anticipated to encourage the regeneration of the patient’s own ligament tissue. The company reports that, to date, results from large-scale animal testing at two years and longer have demonstrated that the L-C Ligament can successfully regenerate a native ligament intra-articularly.
The trial is being conducted at Isala Klinieken in Zwolle, The Netherlands, by van Egmond and at Martini Hospital in Groningen, The Netherlands by Reinoud Brouwer, M.D. A larger, randomized clinical trial in Europe is anticipated to begin in September 2014.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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