Clinical Research Directory

Surgery for Thumb Base Osteoarthritis: Joint Replacement vs. Trapeziectomy

The goal of this clinical trial is to learn if the surgical method with total joint arthroplasty, (TOUCH joint prosthesis), is as good as or better than the traditional surgical method, trapezectomy, to treat thumb base joint osteoarthritis. The main questions it aims to answer are: Does surgery with total joint arthroplasty provide better power grip and pinch grip strength compared to traditional surgery? What is the long-term risk of complications for both methods? Which method is more cost-effective for the healthcare system? Researchers will compare total joint arthroplasty (TOUCH) to trapezectomy (a procedure where a bone in the thumb base is removed) to see which method provides the best results for the patient. Participants will: Be randomized to undergo either an operation with total joint arthroplasty or a trapezectomy. Undergo an initial evaluation and a health economic cost analysis after one year. Attend follow-up checkups at 2, 5, and 10 years post-surgery to evaluate long-term function and the durability of the prosthesis.

TOUCH® CMC 1 New Enrollment US 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.