No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
22 and older
Sex
Any
Study type
Observational
Participants needed
163 (estimated)
Sponsor
Keri Medical SA · Industry
Who this trial is looking for
This trial is looking for adults who need surgery for thumb arthritis. Participants will receive a special prosthesis and help evaluate its effectiveness and safety.
Are You a Good Fit for This Trial?
You may be able to join if
I need thumb joint replacement surgery due to osteoarthritis.
I am 22 years of age or older.
I can sign the study consent form.
You may not be able to join if
I have an infection.
I have severe muscle or nerve problems affecting my thumb.
My bone quality is not good enough for the implant.
My bone size does not fit the implant sizes.
I am allergic to the materials in the prosthesis.
I have another condition that may affect the implant's function.
I am under 22 years of age.
I am pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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City
State
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Status
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 C…
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.
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