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TOUCH® CMC 1 New Enrollment US Study

Recruitingn/aAges 22 Years - anyAllKeri Medical SA
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • TOUCH® CMC 1 Prosthesis
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Where

4 sites
University of Colorado, Anschutz School of Medicine
Aurora, United States
Indiana Hand to Shoulder Center
Indianapolis, United States
Duke University Medical Center, Department of Orthopaedic Surgery
Morrisville, United States
University of Texas Health San Antonio, Department of Orthopaedics
San Antonio, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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