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TOUCH® CMC 1 New Enrollment US Study
RecruitingObservational study
Effectiveness and Safety of the TOUCH® CMC 1 Prosthesis, Post-Approval Study
Who can join
Ages 22 and older · All sexes
Full 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 Consent Exclusion Criteria: 1. Acute or chronic infections, local or systemic 2. Muscular, neurological, or vascular severe deficiency affecting the joint 3. Inadequate bone quality or quantity preventing the implant fixation 4. Bones dimensions incompatible with implant sizes 5. Patients who are allergic to the product's materials 6. Any concomitant disorder that may affect the function of the implant (e.g., osteoarthritis of the wrist) 7. Skeletally immature (i.e., pediatric population, \<22 years of age) 8. Pregnant or nursing women 9. Patients with contraindications to surgery in general 10. Patients with an intellectual disability who cannot follow the instructions of their surgeon.
About the study
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.
What is being tested
- TOUCH® CMC 1 Prosthesis (device)
Sponsor: Keri Medical SA · Participants: 163 · Started: Mar 4, 2026
Contact the study team
- Deborah Caux · Phone: +41 58 611 0062
Official record on ClinicalTrials.gov — NCT07405983
Locations in the U.S.
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.