RecruitingNCT07405983

TOUCH® CMC 1 New Enrollment US Study

Effectiveness and Safety of the TOUCH® CMC 1 Prosthesis, Post-Approval Study

Sponsor

Keri Medical SA

Enrollment

163 participants

Start Date

Mar 4, 2026

Study Type

OBSERVATIONAL

Conditions

Osteoarthritis Thumb Thumb Carpometacarpal Joint Osteoarthritis

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.

Eligibility

Min Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called TOUCH® CMC 1 Prosthesis for people with osteoarthritis thumb and thumb carpometacarpal joint osteoarthritis. The study is currently recruiting participants at 4 locations. People eligible for this study include aged 22 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETOUCH® CMC 1 Prosthesis

The TOUCH® CMC 1 Prosthesis is a commercially available thumb joint implant which is made up of three modular components: 1. TOUCH Cup: a stainless steel trapezial implant (cup) with a dual coating of plasma sprayed titanium and hydroxyapatite; TOUCH Cup is available in two options: Spherical and Conical 2. TOUCH Liner and Neck: a junction implant (neck) topped with a liner pre-assembled to stainless steel neck 3. TOUCH Stem: a titanium alloy metacarpal implant (stem) with a dual coating of plasma sprayed titanium and hydroxyapatite