Effectiveness and Safety of the TOUCH4 CMC 1 Prosthesis, Post-Approval Study

What this Trial Is About

Researchers are evaluating the effectiveness and safety of the TOUCH4 CMC 1 Prosthesis, a cementless, ball-and-socket dual-mobility total joint replacement designed for treating osteoarthritis at the base of the thumb. This post-approval study aims to confirm device performance in newly enrolled patients in the United States compared to data from patients outside the US who previously received the implant. Continued FDA approval requires submission of safety and effectiveness data from this study. The TOUCH4 CMC 1 Prosthesis consists of three modular parts: a stainless steel trapezial implant cup with special coatings, a junction implant with a liner pre-assembled to a stainless steel neck, and a titanium alloy metacarpal implant stem also with dual coatings. The device is surgically implanted to treat symptomatic Eaton-Littler Stage II or III thumb osteoarthritis. The study enrolls adults aged 22 years and older and monitors device performance over time. Participants will undergo surgical implantation of the TOUCH4 CMC 1 Prosthesis by US surgeons. Researchers will assess clinical composite success at 24 months, looking at safety and function of the implant during follow-up. The study involves ongoing monitoring to gather post-approval data required by the FDA, helping to ensure continued reasonable assurance of the device's safety and effectiveness in the US population.

TOUCH® CMC 1 New Enrollment US Study