TOUCH® CMC 1 New Enrollment US Study (PAS002)

Keri Medical SA

Status: Not yet enrolling

Conditions: Thumb Carpometacarpal Joint Osteoarthritis; Osteoarthritis Thumb

Treatments: Device: TOUCH® CMC 1 Prosthesis

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT07405983

TOUCH® CMC 1 New Enrollment US

Details and patient eligibility

About

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.

Full 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.

Enrollment: 163 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

163 participants in 1 patient group

TOUCH® CMC 1 Prosthesis

Treatment:

Device: TOUCH® CMC 1 Prosthesis