| NCT ID | NCT07405983 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Keri Medical SA |
| Condition | Osteoarthritis Thumb |
| Study Type | OBSERVATIONAL |
| Enrollment | 163 participants |
| Start Date | 2026-03-04 |
| Primary Completion | 2029-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 163 participants in total. It began in 2026-03-04 with a primary completion date of 2029-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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, \<22 years of age) 8. Pregnant or nursing women 9. Patients with contraindications to surgery in general 10. Patients with an intellectual disability who cannot follow the instructions of their surgeon.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07405983 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, studying Osteoarthritis Thumb. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07405983 currently recruiting?
Yes, NCT07405983 is actively recruiting participants. Contact the research team at Deborah.Caux@kerimedical.com for enrollment information.
Where is the NCT07405983 trial being conducted?
This trial is being conducted at Aurora, United States, Indianapolis, United States, Morrisville, United States, San Antonio, United States.
Who is sponsoring the NCT07405983 clinical trial?
NCT07405983 is sponsored by Keri Medical SA. The trial plans to enroll 163 participants.