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TOUCH® CMC 1 New Enrollment US Study

NCT07405983 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 163

Last updated 2026-06-04

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • MCRA (an IQVIA business)

    collaborator UNKNOWN

  • Keri Medical SA

    lead INDUSTRY

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-04
Primary Completion
2029-11-30
Completion
2030-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07405983 on ClinicalTrials.gov