Not Yet RecruitingNot Applicable

TOUCH® CMC 1 New Enrollment US Study

163 participantsStarted 2026-03

Plain-language summary

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.

Who can participate

Age range22 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patient requiring 1st carpometacarpal (CMC) primary total joint replacement (arthroplasty) to surgically treat symptomatic Eaton-Littler Stage II or III osteoarthritis (OA)
✓. Adult (≥ 22 years of age) at the time of enrollment
✓. Willing and able to sign the study Informed Consent

Exclusion criteria

✕. Acute or chronic infections, local or systemic
✕. Muscular, neurological, or vascular severe deficiency affecting the joint
✕. Inadequate bone quality or quantity preventing the implant fixation
✕. Bones dimensions incompatible with implant sizes
✕. Patients who are allergic to the product's materials
✕. Any concomitant disorder that may affect the function of the implant (e.g., osteoarthritis of the wrist)
✕. Skeletally immature (i.e., pediatric population, \<22 years of age)
✕. Pregnant or nursing women

What they're measuring

Clinical Composite Success

Timeframe: 24 Months/2 Years

Trial details

NCT IDNCT07405983

SponsorKeri Medical SA

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2029-11

Contact for this trial

Deborah Caux

+41 58 611 0062 Deborah.Caux@kerimedical.com

View on ClinicalTrials.gov More Osteoarthritis Thumb trials