TOUCH® CMC 1 New Enrollment US Study

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Keri Medical SA
Study ID
NCT07405983
Status
Recruiting
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Conditions

  • Osteoarthritis Thumb
  • Thumb Carpometacarpal Joint Osteoarthritis

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Mar 4, 2026
Status verified
Jun 2026
Primary completion
Nov 30, 2029
Completion
Feb 28, 2030

Study Design

Enrollment
163 participants (estimated)

Arms

  • Arm: TOUCH® CMC 1 Prosthesis

Primary Outcome Measure

Clinical Composite Success [ Time Frame: 24 Months/2 Years ]

Central Contacts

Locations (4)

FacilityCityStateZIP
University of Colorado, Anschutz School of MedicineAuroraColorado80045
Indiana Hand to Shoulder CenterIndianapolisIndiana46260
Duke University Medical Center, Department of Orthopaedic SurgeryMorrisvilleNorth Carolina27560
University of Texas Health San Antonio, Department of OrthopaedicsSan AntonioTexas78229

Find similar trials in Aurora, CO

By research site
University of Colorado, Anschutz School of Medicine· Aurora, COIndiana Hand to Shoulder Center· Indianapolis, INDuke University Medical Center, Department of Orthopaedic Surgery· Morrisville, NCUniversity of Texas Health San Antonio, Department of Orthopaedics· San Antonio, TX

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