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Recruiting
NCT07405983
TOUCH® CMC 1 New Enrollment US Study
Conditions: Osteoarthritis Thumb, Thumb Carpometacarpal Joint Osteoarthritis
Sex: All
Ages: 22 Years – N/A
Healthy volunteers: No
Enrollment: 163
Sponsor: Keri Medical SA
Location: University of Colorado, Anschutz School of Medicine Aurora Colorado
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.
Eligibility Criteria
Inclusion Criteria:
1. Patient requiring 1st carpometacarpal (CMC) primary total joint replacement (arthroplasty) to surgically treat symptomatic Eaton-Littler Stage II or III osteoarthritis (OA)
2. Adult (≥ 22 years of age) at the time of enrollment
3. Willing and able to sign the study Informed Consent
Exclusion Criteria:
1. Acute or chronic infections, local or systemic
2. Muscular, neurological, or vascular severe deficiency affecting the joint
3. Inadequate bone quality or quantity preventing the implant fixation
4. Bones dimensions incompatible with implant sizes
5. Patients who are allergic to the product's materials
6. Any concomitant disorder that may affect the function of the implant (e.g., osteoarthritis of the wrist)
7. Skeletally immature (i.e., pediatric population, \
Source: ClinicalTrials.gov (NCT07405983). StuddyBuddy aggregates publicly available trial information.