Recruiting

TOUCH® CMC 1

Sponsor:

Keri Medical SA

Code:

NCT07405983

Conditions

Osteoarthritis Thumb

Thumb Carpometacarpal Joint Osteoarthritis

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

TOUCH® CMC 1 Prosthesis

Study Details

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

Study ID

NCT07405983

Start date

Mar 4, 2026

Status verified date

Jun, 2026

Completion date

Feb, 2030

Anticipated

Primary completion date

Nov, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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 Design

Enrollment

163 participants

Anticipated

Interventions and Outcome Measures

Arms

TOUCH® CMC 1 Prosthesis

Interventions

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

Primary outcome measure

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

Central Contacts and Locations

Locations

University of Colorado, Anschutz School of Medicine

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Principal Investigator:

Louis W Catalano III, MD

Indiana Hand to Shoulder Center

Recruiting

Indianapolis, Indiana, United States, 46260

Contacts

Principal Investigator:

Thomas Kaplan, MD

Duke University Medical Center, Department of Orthopaedic Surgery

Recruiting

Morrisville, North Carolina, United States, 27560

Contacts

Principal Investigator:

Tyler Pidgeon, MD

More Information

Sponsor

Keri Medical SA

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Keri Medical SA on 2026-06-04.