NCT07405983

TOUCH® CMC 1 New Enrollment US Study

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 163 (estimated)
• Sponsor: Keri Medical SA · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Detailed description

TOUCH® CMC 1 (Carpometacarpal) Prosthesis is a cementless, ball-and-socket dual-mobility, total CMC1 joint replacement prosthesis, designed to treat osteoarthritis of the base of the thumb. The TOUCH® CMC 1 Prosthesis was approved by FDA (P240020) on July 10, 2025. Continued approval of the premarket approval application (PMA) is contingent upon the submission of periodic reports (Annual Report), required under 21 CFR 814.84. In order to provide continued reasonable assurance of the safety and effectiveness of the PMA device, data from this post-approval study must be submitted to FDA in a PMA Post Approval Study Report per the requirements set forth in the approval.

Conditions

• Osteoarthritis Thumb
• Thumb Carpometacarpal Joint Osteoarthritis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-03-01
• Primary completion: 2029-11-01
• Completion: 2030-02-01
• First posted: 2026-02-12
• Last updated: 2026-02-12

Regulatory

• FDA-regulated device study