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This study will evaluate whether Cartiva is an effective treatment for individuals with osteoarthritis of the first CMC joint in the hand compared to LRTI.
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This is a prospective, multicenter study with one treatment arm. Comparisons will be made to a performance target defined by subtracting a non-inferiority margin of 0.05 from an expected standard of care success rate of 0.55. The active treatment arm will receive a Cartiva® SCI for CMC.
A total of 74 subjects will be enrolled into the pivotal study.
Follow up visits will occur at the following time points after the surgical procedure: 2 week, 6 week, 3 month, 6 month, 1 year, 2 year, 3 year, 4 year and 5 year.
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74 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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