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Indiana Hand to Shoulder Center, an OrthoIndy practice, is officially the first site to enroll a patient in the first U.S. clinical study (NCT #7405983) of Keri Medical’s TOUCH® CMC 1 Prosthesis, a total joint replacement implant for the thumb, which is distributed in the U.S. by Medartis Inc.
The patient, enrolled by Dr. F. Thomas D. Kaplan, assisted by Dr. Brandon Smetana, is the first in a 163-patient post-approval study commitment to the U.S. Food and Drug Administration (FDA).
Addressing debilitating thumb arthritis
The TOUCH® CMC 1 Prosthesis is intended for use in first carpometacarpal (CMC) primary total joint replacement in patients with symptomatic Eaton-Littler Stage II or Stage III osteoarthritis. In osteoarthritic joints, the cartilage wears down, leaving the underlying bone surfaces to grind on each other. Thumb arthritis is a common and often debilitating disease which can cause significant pain and impacts grip strength, hand function and overall quality of life.
During the first U.S. study of the TOUCH® CMC 1 Prosthesis, patients will be followed for a minimum of two years to observe the rate of pain reduction and functional improvement.
“We are excited to help launch the first U.S. study that will provide insight into the benefits of total joint replacement for patients suffering from debilitating thumb arthritis,” said Dr. Kaplan, fellowship director and managing partner at Indiana Hand to Shoulder Center. “Our patients deserve a better option that may provide quicker recovery and better strength than traditional surgery. This study has the potential to pave the way for a paradigm shift in how U.S. surgeons treat thumb arthritis – just as hip replacement surgery did decades ago.”
A new option in thumb joint replacement
The TOUCH® CMC 1 Prosthesis features several design firsts on the U.S. market – all aimed at durability, long-term structural integrity, and expanded range of motion in the joint. FDA approval (PMA 240020) of this cementless, dual mobility total CMC prosthesis was supported by a body of clinical evidence established in over a decade of market presence in Europe.
The TOUCH® CMC 1 Prosthesis addresses a critical need in the U.S., as well. While osteoarthritis is more common in older people, anyone can develop it.
“Thumb CMC osteoarthritis is particularly common with aging, and a large percentage of our population may benefit from expanded treatment options,” said Dr. Smetana, a board-certified orthopedic surgeon, nerve surgeon and director of research at Indiana Hand to Shoulder Center. “Advancements like the TOUCH® CMC 1 Prosthesis are an important next step in making innovative care more widely available, and we’re proud to help make that possible with inclusion in this post-approval study.”
Indiana Hand to Shoulder Center was selected as one of the first participating study sites nationwide due, in part, to its reputation as an internationally known training center for hand surgeons and its tradition of strong clinical research. Drs. Kaplan and Smetana travelled to Europe for intensive training in the procedure, and now, several other surgeons at Indiana Hand to Shoulder Center are trained to perform it.
The TOUCH® CMC 1 Prosthesis has been commercially available in the United States since July 2025. Study enrollment is not a requirement for surgery. Patients who believe they may be candidates are encouraged to consult with their physician.
Patients who want to learn more about the TOUCH® CMC 1 prosthesis from Keri Medical can visit kerimedical.us or contact Medartis at medartisusa.com. To learn more about Indiana Hand to Shoulder Center, an OrthoIndy practice, visit indianahandtoshoulder.com.
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