First 50 Patients Enrolled in Cartilage Study
Biloine W. Young • Fri, May 12th, 2017
Cartiva Inc. of Alpharetta, Georgia, has completed enrollment and treatment of all 50 patients in a multi-center study evaluating the safety and effectiveness of Cartiva’s Synthetic Cartilage Implant (SCI) for first carpometacarpal (CMC) joint osteoarthritis at the base of the thumb.
The company conducted the study at nine sites in Canada and the United Kingdom.
Basal thumb arthritis afflicts more than two million American adults, up to one-third of whom are post-menopausal women.
Osteoarthritis of the CMC joint--- also known as thumb basal joint arthritis -impacts 8% to 12% of the general population and as many as 33% of postmenopausal women. It causes pain, swelling, instability, deformity, loss of motion and weakness, making it difficult to perform a variety of tasks, such as turning doorknobs and opening jars.
Cartiva SCI is a biocompatible polymer device designed to mimic natural cartilage. The Company received Premarket Approval from the FDA to commercialize Cartiva SCI to treat osteoarthritis at the base of the great toe.
The thumb implant treats osteoarthritis in patients with diseased or damaged articular surface in the first CMC joint. It is implanted in the metacarpal base to replace damaged cartilage without destroying or removing healthy tissue. According to the company’s press release, the implant’s design minimizes bone resection while preserving the trapezium.
Philip Sauve, a Consultant and Orthopaedic Surgeon at Queen Alexandra Hospital in Portsmouth, England has treated twelve patients with Cartiva. He said, “So far we have had good results. Their pain is reducing, their grip strength is increasing and so their function is improving. These early results are very promising but we will have to wait to see how the Cartiva implant performs over a longer period of time. For that group of patients who are still working and still very active, I think it's a really good option."
In February of last year the Company attended a pre-submission meeting with the (FDA). It plans to review the interim six-month results next month.