Touch CMC 1 Thumb Joint Replacement in US: New Enrollment Observational Study
Official title: Effectiveness and Safety of the TOUCH® CMC 1 Prosthesis, Post-Approval Study
Run by Keri Medical SA · NCT07405983 · Data updated 2026-11-12
This US post-approval study tests how well the TOUCH CMC 1 prosthesis works and stays safe for people with thumb base arthritis who need a first CMC joint replacement.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 22 Years and up |
| Sex | All |
| Enrollment | 163 (estimated) |
| Sponsor | Keri Medical SA Industry-sponsored |
| Locations | 4 sites (Aurora, Colorado and 3 other locations) |
| Status | Recruiting |
| Started | March 4, 2026 |
| Main results expected | November 2029 |
| Study ends | February 2030 |
| Registry record updated | June 4, 2026 |
| Trial ID | NCT07405983 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 22 years and older with symptomatic Eaton-Littler stage II or III thumb base OA requiring a primary 1st CMC joint replacement, who can consent.
✕Probably not a fit
Patients with active infection, poor bone quality, allergic reactions to implant materials, or other factors that contraindicate surgery may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study collects data on adult patients undergoing first carpometacarpal joint replacement with the TOUCH CMC 1 prosthesis in the United States. It compares outcomes from US patients to outcomes seen in the premarket international cohort. Participants are adults 22 and older with Eaton-Littler stage II or III thumb OA and must meet standard surgical eligibility with informed consent. The study is led by Keri Medical SA with MCRA and is conducted at multiple US centers. FDA post-approval reporting requirements guide the ongoing data submission.
Why it matters
Potential benefit: If successful, the study could confirm the prosthesis safety and effectiveness in US patients and support continued regulatory oversight.
How similar studies have gone: Prior international post-approval data for TOUCH CMC 1 informed performance; this US cohort aims to corroborate those findings in a US population.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
University of Colorado, Anschutz School of Medicine
Aurora, Colorado, United States Recruiting -
Indiana Hand to Shoulder Center
Indianapolis, Indiana, United States Recruiting -
Duke University Medical Center, Department of Orthopaedic Surgery
Morrisville, North Carolina, United States Recruiting -
University of Texas Health San Antonio, Department of Orthopaedics
San Antonio, Texas, United States Not yet recruiting
Study contacts
- Study coordinator: Deborah Caux
- Email: Deborah.Caux@kerimedical.com
- Phone: +41 58 611 0062
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Thumb base arthritis: joint replacement vs trapeziectomy
This trial tests whether a total thumb joint replacement (TOUCH prosthesis) works as well as trapeziectomy for people with basal thumb arthritis.
-
National Registry for Artery Embolization to Treat Chronic Pain
This study is testing if a procedure that blocks blood flow to painful areas can help people with chronic pain from osteoarthritis and other conditions feel better.
-
Examining biomarkers in osteoarthritic thumb joints
This study is testing how certain markers in the thumb joints of people with osteoarthritis relate to their overall health and comparing them to knee joints, while also looking at grip strength and pain before and after surgery.
-
Surgery to fuse finger joints using the Kerifuse device
This study is testing a new device to see if it helps fuse finger joints in people with osteoarthritis faster and better than current methods.
-
Improving thumb strength and function for arthritis patients
This study is testing different surgical options for people with thumb arthritis to see which one helps improve strength, function, and reduce pain the most.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.