TOUCH® CMC 1 New Enrollment US Study
Recruiting
Observational Study
Osteoarthritis Thumb
Thumb Carpometacarpal Joint Osteoarthritis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 22 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 163 (estimated)
- Sponsor
- Keri Medical SA · Industry
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About This Trial
The purpose of this study is to meet a PMA (P240020) condition of approval of the TOUCH® CMC 1 Prosthesis to evaluate the effectiveness and safety of the prosthesis in the United States (US) population. The device performance in newly enrolled US patients implanted by US surgeons will be compared to device performance observed within the outside the US (OUS) premarket cohort.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Patient requiring 1st carpometacarpal (CMC) primary total joint replacement (arthroplasty) to surgically treat symptomatic Eaton-Littler Stage II or III osteoarthritis (OA)
2. Adult (≥ 22 years of age) at the time of enrollment
3. Willing and able to sign the study Informed C…
Contacts