Assessing 2-week to 2-year outcome of synthetic cartilage implant versus 1st MTPJ arthrodesis .
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Prospective, Randomized, Multi-centered Clinical Trial Assessing Safety and Efficacy of a Synthetic Cartilage Implant Versus First Metatarsophalangeal Arthrodesis in Advanced Hallux Rigidus
Foot Ankle Int. 2016 May;37(5):457-69219 patients - 197 randomized and 22 nonrandomized - were included in this study comparing the outcome of treatment for hallux rigidus between a synthetic hydrogel implant (Cartiva) and 1st metatarsophalangeal joint (MTPJ) arthrodesis over a 2-year follow-up. The primary outcome was the rate of patients who attained a composite endpoint of; a minimum 30% decrease in pain on a visual analog scale (VAS), maintenance or improvement in Foot and Ankle Ability Measure (FAAM) sports subscore relative to baseline, and no development of any major adverse event. Based on noninferiority analysis of the primary outcome, the Cartiva group was noninferior to the arthrodesis group. The range of 1st MTPJ dorsiflexion was significantly greater in the Cartiva group throughout follow-up, but VAS pain scores were also significantly greater in the Cartiva group throughout follow-up as well.
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