TOUCH® CMC 1 New Enrollment US Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age22+
SponsorKeri Medical SA
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- TOUCH® CMC 1 Prosthesis
Treatment groups
163 Participants
are divided into 1 treatment groupSponsors and collaborators
Keri Medical SA
Lead sponsor
MCRA (an IQVIA business)
Collaborator
Source ClinicalTrials.gov