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| Name | Class |
|---|---|
| MCRA (an IQVIA business) | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TOUCH® CMC 1 Prosthesis |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical Composite Success |
| 24 Months/2 Years |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects participating in this study will be recruited from the investigators' standard patient populations. All patients presenting with osteoarthritis of the 1st carpometacarpal joint will be evaluated for study participation based on the inclusion/exclusion criteria. Subjects must meet all of the following inclusion criteria and none of the exclusion criteria. The investigator maintains exclusive responsibility for the inclusion and exclusion of any potential study participant.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deborah Caux | Contact | +41 58 611 0062 | Deborah.Caux@kerimedical.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado, Anschutz School of Medicine | Recruiting | Aurora | Colorado | 80045 | United States |
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| Indiana Hand to Shoulder Center | Recruiting | Indianapolis | Indiana | 46260 | United States |
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| Duke University Medical Center, Department of Orthopaedic Surgery | Recruiting | Morrisville | North Carolina | 27560 | United States |
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| University of Texas Health San Antonio, Department of Orthopaedics | Not yet recruiting | San Antonio | Texas | 78229 | United States |
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