Thumb Joint Implant Study for Thumb Base Osteoarthritis in the United States
Looks at how well a thumb joint implant works and its safety.
Key facts
- Who runs it
- Keri Medical SA
- Where
- Aurora, Indianapolis, Morrisville, and San Antonio, United StatesSee the 4 sites
- Trial code
- Registry title
- TOUCH® CMC 1 New Enrollment US Study
- Status
- Recruiting
- People taking part
- 163 people, planned
- Started
- 4 Mar 2026
- Expected to end
- Feb 2030
- Type of study
- Observational
- Treatments tested
- TOUCH® CMC 1 Prosthesis
- Record updated
- 4 June 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who need a first-time total joint replacement at the base of the thumb because of painful osteoarthritis. They will get the TOUCH® CMC 1 Prosthesis.
- Age
- 22 years and older
- Sex
- All sexes
- Disease stage
- Osteoarthritis of the thumb base joint (1st carpometacarpal joint) with symptoms, Eaton-Littler Stage II or III
- Earlier treatment
- The joint replacement must be a first (primary) replacement of this joint.
Main reasons for not taking part
- Infection in the area or in the body, short-term or long-term
- Severe muscle, nerve or blood vessel problems affecting the joint, or bone too weak or too little to hold the implant
- Allergy to the implant materials, or another joint problem such as wrist osteoarthritis
- Pregnant or breastfeeding women
- Unable to have surgery, or an intellectual disability that prevents following the surgeon's instructions
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- 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
Who cannot take part
- Inadequate bone quality or quantity preventing the implant fixation
- Bones dimensions incompatible with implant sizes
- Any concomitant disorder that may affect the function of the implant (e.g., osteoarthritis of the wrist)
- Patients with contraindications to surgery in general
- Acute or chronic infections, local or systemic
- Patients who are allergic to the product's materials
- Skeletally immature (i.e., pediatric population, <22 years of age)
- Muscular, neurological, or vascular severe deficiency affecting the joint
- Pregnant or nursing women
- Patients with an intellectual disability who cannot follow the instructions of their surgeon
Where in United States
- University of Colorado Anschutz School of MedicineAurora, United StatesContact: Layla HajiTaking people
- Indiana Hand to Shoulder CenterIndianapolis, United StatesContact: Melanie GloverTaking people
- Duke University Medical Center, Department of Orthopaedic SurgeryMorrisville, United StatesContact: Jacob CarpenterTaking people
- University of Texas Health San Antonio, Department of OrthopaedicsSan Antonio, United StatesContact: Nick LucioNot yet recruiting
About the trial
What the trial wants 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.
The group in the trial
- TOUCH® CMC 1 Prosthesis
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effectiveness and Safety of the TOUCH® CMC 1 Prosthesis, Post-Approval Study
- Plain-language title
- Thumb Joint Implant Study for Thumb Base Osteoarthritis in the United StatesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 4 June 2026