TOUCH® CMC 1 New Enrollment US Study
Recruiting · NCT07405983 · Observational (researchers observe without assigning treatment) · Lead sponsor: Keri Medical SA
View the official record on ClinicalTrials.gov →Interventions studied
TOUCH® CMC 1 Prosthesis
What this trial is 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.
Who can take part
Age range
22 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Patient requiring 1st carpometacarpal (CMC) primary total joint replacement (arthroplasty) to surgically treat symptomatic Eaton-Littler Stage II or III osteoarthritis (OA)
- Adult (≥ 22 years of age) at the time of enrollment
- Willing and able to sign the study Informed Consent
Exclusion criteria
- Acute or chronic infections, local or systemic
- Muscular, neurological, or vascular severe deficiency affecting the joint
- Inadequate bone quality or quantity preventing the implant fixation
- Bones dimensions incompatible with implant sizes
- Patients who are allergic to the product's materials
- Any concomitant disorder that may affect the function of the implant (e.g., osteoarthritis of the wrist)
- Skeletally immature (i.e., pediatric population, \<22 years of age)
- Pregnant or nursing women
- Patients with contraindications to surgery in general
- Patients with an intellectual disability who cannot follow the instructions of their surgeon.
Where it is running
4 locations listed across 4 US states.
- University of Colorado, Anschutz School of Medicine - Aurora, Colorado, United States
- Indiana Hand to Shoulder Center - Indianapolis, Indiana, United States
- Duke University Medical Center, Department of Orthopaedic Surgery - Morrisville, North Carolina, United States
- University of Texas Health San Antonio, Department of Orthopaedics - San Antonio, Texas, United States