TOUCH® CMC 1 New Enrollment US Study (PAS002)

June 2, 2026 updated by: Keri Medical SA

Effectiveness and Safety of the TOUCH® CMC 1 Prosthesis, Post-Approval Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

TOUCH® CMC 1 (Carpometacarpal) Prosthesis is a cementless, ball-and-socket dual-mobility, total CMC1 joint replacement prosthesis, designed to treat osteoarthritis of the base of the thumb. The TOUCH® CMC 1 Prosthesis was approved by FDA (P240020) on July 10, 2025. Continued approval of the premarket approval application (PMA) is contingent upon the submission of periodic reports (Annual Report), required under 21 CFR 814.84. In order to provide continued reasonable assurance of the safety and effectiveness of the PMA device, data from this post-approval study must be submitted to FDA in a PMA Post Approval Study Report per the requirements set forth in the approval.

Study Type

Observational

Enrollment (Estimated)

163

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado, Anschutz School of Medicine
        • Contact:
        • Principal Investigator:
          • Louis W Catalano III, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Recruiting
        • Indiana Hand to Shoulder Center
        • Principal Investigator:
          • Thomas Kaplan, MD
        • Contact:
    • North Carolina
      • Morrisville, North Carolina, United States, 27560
        • Recruiting
        • Duke University Medical Center, Department of Orthopaedic Surgery
        • Principal Investigator:
          • Tyler Pidgeon, MD
        • Contact:
    • Texas
      • San Antonio, Texas, United States, 78229
        • Not yet recruiting
        • University of Texas Health San Antonio, Department of Orthopaedics
        • Contact:
        • Principal Investigator:
          • Brian Sager, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TOUCH® CMC 1 Prosthesis
Device: TOUCH® CMC 1 Prosthesis

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Composite Success
Time Frame: 24 Months/2 Years
  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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Keri Medical SA

Collaborators

MCRA (an IQVIA business)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2026

Primary Completion (Estimated)

November 1, 2029

Study Completion (Estimated)

February 1, 2030

Study Registration Dates

First Submitted

February 5, 2026

First Submitted That Met QC Criteria

February 5, 2026

First Posted (Actual)

February 12, 2026

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • TOUCH® CMC 1 New Enrollment US

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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