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
This trial does not accept healthy volunteersQualifiers
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 population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
TOUCH® CMC 1 Prosthesis
DeviceThe 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
Treatment groups
163 Participants
are divided into 1 treatment groupGroup A: TOUCH® CMC 1 Prosthesis1 intervention
Trial outcomes
Primary outcomes
1
Clinical Composite Success
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
Time frame
24 Months/2 YearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Keri Medical SA
Lead sponsor
MCRA (an IQVIA business)
Collaborator
Source ClinicalTrials.gov