NCT07405983 · Keri Medical SA
TOUCH® CMC 1 New Enrollment US Study
(PAS002)
What this study is about
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 group of participants.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patient requiring 1st carpometacarpal (CMC) primary total joint replacement (arthroplasty) to surgically treat symptomatic Eaton-Littler Stage II or III osteoarthritis (OA)
- Adult (≥ 22 years of age) at the time of enrollment
- Willing and able to sign the study Informed Consent
Exclusion criteria
- Acute or chronic infections, local or systemic
- Muscular, neurological, or vascular severe deficiency affecting the joint
- Inadequate bone quality or quantity preventing the implant fixation
- Bones dimensions incompatible with implant sizes
- Patients who are allergic to the product's materials
- Any concomitant disorder that may affect the function of the implant (e.g., osteoarthritis of the wrist)
- Skeletally immature (i.e., pediatric population, \<22 years of age)
- Pregnant or nursing women
- Patients with contraindications to surgery in general
- Patients with an intellectual disability who cannot follow the instructions of their surgeon.
Where
- Aurora, Colorado
- Indianapolis, Indiana
- Morrisville, North Carolina
- San Antonio, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 4, 2026 · Source of record for eligibility and locations