New Cartilage Implant Treats Osteoarthritis of the Big Toe

A novel biomedical polymer implant mimics the physical characteristics of articular cartilage, relieving pain while maintaining joint function.

The Cartiva Synthetic Cartilage Implant (SCI) is intended for use in the treatment of patients with painful arthritis at the base of the great toe as an alternative to fusion, providing pain relief and improvement in both function and motion by replacing damaged cartilage. Made of an organic polymer-based biomaterial comprised of 40% polyvinyl alcohol (PVA) and saline, the cylindrical synthetic polymer provides cartilage-like compressible, low-friction, and a durable bearing surface.

The SCI is placed in a single surgical procedure, addressing focal articular defects. Due to the similar osmotic, physical, and frictional properties of Cartiva SCI to native cartilage, joint-resurfacing repairs using this implant does not require replacement of the opposing articular surface. Consequently, the procedure does not require significant removal of healthy tissue, resulting in nominal surgical trauma and rapid recovery. The procedure takes about 35 minutes and, unlike fusion, allows the patient to immediately bear weight.

A randomized, multicenter, 236-patient clinical trial that compared outcomes from patients who received the SCI with patients who underwent fusion showed that the SCI group posted a 93% reduction in median pain and a 168% improvement in median function in sporting activities, and a 65% improvement in daily living activities. SCI patients also had a 26% increased range of movement from baseline. The Cartiva SCI is a product of Cartiva (Alpharetta, GA, USA), and has been approved by the U.S. Food and Drug Administration (FDA).

“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,” said Mark Glazebrook, MD, of the Queen Elizabeth II Health Sciences Centre (Halifax, Canada). “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.”

PVA is derived from polyvinyl acetate through partial or full hydroxylation. Depending on the degree of polymerization and hydrolysis, the physical characteristics, chemical properties, and mechanical properties of PVA can be customized to defined functional requirements. Properties can be further modified by crosslinking, which results in a material that can be swollen to produce a hydrogel. PVA’s properties also make it a good replacement for cartilage, which is typically comprised of 60-80% water, with a mass balance primarily of collagen.

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