TOUCH® CMC 1 New Enrollment US Study

NCT07405983 | Not Yet Recruiting FDA Device

• 1 other identifier: TOUCH® CMC 1 New Enrollment US
• Study Type: observational
• Target: 163
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoarthritis Thumb; Thumb Carpometacarpal Joint Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Clinical Composite Success

  1. Improvement of pain: A clinically meaningful improvement in pain during activities defined as a decrease in the Numerical Rating Scale (NRS) pain score of ≥ 30% on a 10-point scale. 2. Maintenance or improvement in function: defined by key pinch strength, which is ≥ 85% of the subject's pre-operative key pinch strength. 3. Safety: success is defined as freedom from: * Subsequent surgical interventions (SSI) (i.e., reoperation, revision, removal of any study component, or supplemental fixations) on the study carpometacarpal joint, or * Serious, device- or procedure-related adverse events

  24 Months/2 Years

Study Arms (1)

TOUCH® CMC 1 Prosthesis

Device: TOUCH® CMC 1 Prosthesis

Interventions

TOUCH® CMC 1 Prosthesis DEVICE

The TOUCH® CMC 1 Prosthesis is a commercially available thumb joint implant which is made up of three modular components: 1. TOUCH Cup: a stainless steel trapezial implant (cup) with a dual coating of plasma sprayed titanium and hydroxyapatite; TOUCH Cup is available in two options: Spherical and Conical 2. TOUCH Liner and Neck: a junction implant (neck) topped with a liner pre-assembled to stainless steel neck 3. TOUCH Stem: a titanium alloy metacarpal implant (stem) with a dual coating of plasma sprayed titanium and hydroxyapatite

TOUCH® CMC 1 Prosthesis

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects participating in this study will be recruited from the investigators' standard patient populations. All patients presenting with osteoarthritis of the 1st carpometacarpal joint will be evaluated for study participation based on the inclusion/exclusion criteria. Subjects must meet all of the following inclusion criteria and none of the exclusion criteria. The investigator maintains exclusive responsibility for the inclusion and exclusion of any potential study participant.

You may qualify if:

• 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

You may not qualify if:

• Acute or chronic infections, local or systemic
• Muscular, neurological, or vascular severe deficiency affecting the joint
• Inadequate bone quality or quantity preventing the implant fixation
• Bones dimensions incompatible with implant sizes
• Patients who are allergic to the product's materials
• Any concomitant disorder that may affect the function of the implant (e.g., osteoarthritis of the wrist)
• Skeletally immature (i.e., pediatric population, \<22 years of age)
• Pregnant or nursing women
• Patients with contraindications to surgery in general
• Patients with an intellectual disability who cannot follow the instructions of their surgeon.

Sponsors & Collaborators

• Keri Medical SA: lead
• MCRA (an IQVIA business): collaborator

Central Study Contacts

Deborah Caux

CONTACT

+41 58 611 0062; Deborah.Caux@kerimedical.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 12, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): February 1, 2030
• Last Updated: February 12, 2026

Record last verified: 2026-02