Study Shows Eight-Year Effectiveness for Cartiva Synthetic Cartilage Implant

A new study highlights the Cartiva synthetic cartilage implant (SCI) and concludes that the device, made by Alpharetta, Ga.-based Cartiva Inc., is effective for up to eight years in patients with focal cartilage injuries in the knee. Cartiva SCI is a proprietary polyvinyl alcohol (PVA) hydrogel that was designed to mimic natural cartilage.

Articular cartilage is the smooth, white tissue that lines the bony surface of the knee and provides lubrication and distribution of weight. Even though articular cartilage is durable, injuries are common and can occur as a result of athletic activity, traumatic injury or daily wear and tear. Unlike bone and other connective tissue types, articular cartilage has no direct blood supply, and thus little capacity to repair itself. Left untreated, these discrete, or focal, cartilage injuries can progressively worsen and lead to chronic conditions such as osteoarthritis. Focal cartilage injuries can cause stiffness, joint pain and decreased range of motion.

“Despite the various treatment options available, symptomatic articular cartilage defects continue to represent a therapeutic challenge for knee surgeons,” said Fabio V. Sciarretta, M.D. of the Clinica Nostra Signora della Mercede in Rome, Italy and lead investigator of the study. “The results of this study suggest that Cartiva SCI may play an important role as a first-line treatment option for painful cartilage defects in carefully selected patients. Long-term sustainability of treatment response is very important to this patient population, and in this study we saw statistically significant improvements out as long as eight years.”

Study Design and Results

The single-site study, titled “Five to eight years follow-up of knee chondral defects treated by PVA-H hydrogel implants,” included 25 patients with Grade III and IV focal chondral and osteochondral defects of the knee that were treated with Cartiva SCI. Of the 25 patients, follow-up was obtained on 18 patients (one of whom was treated bilaterally), with a mean follow up of 68.4 months and a range of 38-96 months. General patient health and knee joint function were recorded and analyzed pre-operatively and at latest follow up using the SF-36 and the 2000 International Knee Documentation Committee (IKDC). IKDC is a validated knee assessment tool developed by the International Cartilage Research Society that asks patients questions pertaining to their symptoms (pain, swelling and stiffness), knee function and sporting activities. An improved IKDC score can be correlated to an improvement in a patient’s clinical symptoms (reduced pain, swelling and/or stiffness), a return to sporting activities and improved knee function for activities of daily living. The IKDC score incorporates physician findings and results from a comprehensive knee exam and X-ray review.

The published study results demonstrate that implantation with Cartiva SCI resulted in a statistically significant increase from baseline in IKDC scores. The mean pre-operative IKDC scores across all 19 knees receiving an implant was 32.53, ranging from a low of 19.54 to a high of 47.12. At last follow-up, the majority of patients showed significant improvement over pre-operative values of IKDC score, with an average increase of 43.27 (5.25) points. Individual change from pre-operative scores ranged from a slight loss of 4.60 to a gain of 71.27 points. Nearly half (47.4 percent) of patients had an improvement of more than 50 points in their IKDC score.

Patient satisfaction for the procedure was high, with more than 85 percent of patients at their last follow-up visit indicating improvement after the procedure and satisfaction with the results. Follow-up MRI images also revealed a normal healing process, with no signs of osteolysis or implant wear.

“The findings of this peer-reviewed study further validate the potential clinical and patient benefits of Cartiva SCI in the treatment of focal cartilage defects,” said Timothy J. Patrick, president and CEO of Cartiva. “We believe there is a significant clinical need for patients with cartilage damage and limited options due to their age, lesion size or lifestyle. Cartiva SCI is a long-term and cost-effective solution that addresses this need with the added benefits of off the shelf availability, a single, quick and less invasive procedure, immediate weight bearing and a short rehabilitation program.”

Cartiva SCI is intended to treat focal chondral or osteochondral defects of the articular cartilage surface associated with joint pain or decreased range of motion. With water content similar to surrounding healthy cartilage and its ability to withstand physiologic loading, the elastic and compressive mechanical properties of Cartiva SCI are mean to make it a good replacement for damaged articular cartilage. The viscoelastic surface replacement provides flexible cushioning intended to maintain natural joint mechanics by repairing focal cartilage defects, while minimizing the resection of healthy tissue, the company claims. Cartiva SCI is implanted in a single procedure similar to that used for osteochondral autograft or allograft transplantation, by placing the device in a pre-drilled hole to resurface the damaged area of cartilage.

Cartiva SCI is currently available in Canada, Europe and South America, but is not available for sale or use in the United States.