FDA Approves First Ever Synthetic Joint Implant
For patients suffering from painful osteoarthritis in the forefoot, the first metatarsophalangeal (MTP) joint is a typical problem area. The US Food and Drug Administration (FDA) announced the approval of the Cartiva Synthetic Cartilage Implant (SCI), an artificial joint implant capable of providing significant functional relief from arthritis that stems from the base of the big toe. The device is the first ever synthetic cartilage device to receive approval by the FDA.
Current standard of care practices fuse the bones together using screws and plates. This procedure can eliminate the pain significantly, but it also takes away functional movement in the joint. The Cartiva SCI device is an alternative to fusion, providing pain relief but also improving range of motion in the joint instead of taking it away, noted the agency
“Before Cartiva SCI, the options we could provide to patients with osteoarthritis of the great toe were limited, as the fusion procedure often necessitates sacrificing range of motion to get pain relief,” Dr. Mark Glazebrook of the Queen Elizabeth II Health Sciences Centre in Halifax, Nova Scotia, said in a press release from the implant’s manufacturer.
“Due to the simplicity of the procedure, speed of recovery and range of motion benefits, I see that patients are relieved to have this option available to them and the majority are electing Cartiva over fusion,” said Dr. Glazebrook, who currently uses the product in his own practice.
Shaped like a small cylinder, the Cartiva SCI device is a biocompatible, biomedical polymer implant with a high water content and elastic, mechanical properties that make it a durable viscoelastic replacement for damaged articular cartilage. With its compression- and wear-resistant technologies, the artificial joint has been designed to withstand the repetitive loading typically inflicted on the MTP joint.
Because joint resurfacing repairs utilizing Cartiva SCI do not require replacing the opposing articular surface, the implantation procedure can be done in approximately 35 minutes on an outpatient basis. The procedure does not require significant removal of healthy tissue or replacement with a durable bearing surface, which helps to ensure nominal surgical trauma and rapid recovery, and unlike the fusion procedure, patients can begin weight-bearing on the joint as soon as tolerated.
New Clinical Evidence of Efficacy
In April, 2016, the FDA's Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee recommended the approval of the implant, which was supported by new clinical evidence published in the May issue of Foot and Ankle International.1
The research found supportive evidence of the device’s efficacy and safety as a cartilage bone implant to the first MTP arthrodesis in patients with advanced-stage hallux rigidus.
The MOTION study was a prospective, randomized non-inferiority trial that enrolled 236 patients. A final cohort makeup of 152 patients receiving the implant were compared to 50 patients receiving the gold standard of a great toe arthrodesis.
Both cohorts showed significant pain reduction and improvements in activity scores from baseline over the next 1 to 2 years following their respective procedures. Both patient groups also had similarly low rates of secondary surgeries and complications following their procedures. Overall, patients receiving the Cartiva SCI showed an 80% clinical success rate after 2 years compared to the 79% of patients receiving a fusion procedure.
There were no cases of implant fragmentation, wear, or bone loss. And patients using the Cartiva SCI device reported a significant 93% reduction in median pain. Median function in sporting activities also increased by 168% and daily living function increased by 65%. Even range of motion improved by 26% compared to the baseline scores taken before the device was implanted.
Researchers concluded that the Cartiva SCI device was an “excellent alternative to arthrodesis in patients who wished to maintain first MTP motion,” and given only 10% of the implant group required revision to arthrodesis at 2 years, the implant appears to have viable durability and safety for long term use.1
The Cartiva SCI device is being manufactured by Cartiva Incorporated, a private, venture capital-backed company based out of Alpharetta, Georgia. More information about the product can be found on their official website.