Safety and Effectiveness of Cartiva Implant in the Treatment of First CMC Joint Osteoarthritis Compared to LRTI (GRIP 2)

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.

Inclusion Criteria:

- ≥ 22 years of age

- Refractory to conservative non-operative standard of care treatment for first CMC OA
lasting for at least 6 months that requires surgical intervention

- Eaton classification stage II or III OA of the first CMC joint based on X-rays taken
within 6 months of the Operative date and evidence of first CMC joint OA based on
subjective review of associated clinical symptoms

- Be willing and able to return for all study-related follow up procedures

Exclusion Criteria:

- Previous CMC implant, trapeziectomy, or LRTI to the affected joint to be treated

- History of or current diagnosis of rheumatoid arthritis

- OA of the scaphotrapeziotrapezoidal (STT) joint based on radiographic assessment in
the hand to be treated

- Any disease, including uncontrolled diabetes mellitus, which is clinically known to
impact wound healing ability

- Known or suspected allergic reaction to polyvinyl alcohol