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NOT YET RECRUITING
NCT07405983

TOUCH® CMC 1 New Enrollment US Study

Sponsor: Keri Medical SA

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

22 Years - Any

Study Type

OBSERVATIONAL

Enrollment

163

Start Date

2026-03

Completion Date

2030-02

Last Updated

2026-02-12

Healthy Volunteers

No

Interventions

DEVICE

TOUCH® 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