Osteoarthritis Thumb, Thumb Carpometacarpal Joint Osteoarthritis
Conditions
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.
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.
Interventions
DEVICETOUCH® 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
Keri Medical SA
MCRA (an IQVIA business)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Composite Success | 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 |
Countries
United States
Contacts
CONTACTDeborah Caux
Outcome results
None listed