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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

Sponsor: Keri Medical SA · Participants: 163 · Started: Mar 4, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07405983

Locations in the U.S.

ColoradoUniversity of Colorado, Anschutz School of Medicine, Aurora
IndianaIndiana Hand to Shoulder Center, Indianapolis
North CarolinaDuke University Medical Center, Department of Orthopaedic Surgery, Morrisville
TexasUniversity of Texas Health San Antonio, Department of Orthopaedics, San Antonio (Not yet recruiting)

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.