TOUCH® CMC 1 Prosthesis: The 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
Study summary
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
Sex
ALL
Min age
22 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Clinical Composite Success — 24 Months/2 Years 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
Trial sites (4)
Facility
City
Region
Status
University of Colorado, Anschutz School of Medicine
Aurora
Colorado
Recruiting
Indiana Hand to Shoulder Center
Indianapolis
Indiana
Recruiting
Duke University Medical Center, Department of Orthopaedic Surgery
Morrisville
North Carolina
Recruiting
University of Texas Health San Antonio, Department of Orthopaedics
San Antonio
Texas
Not Yet Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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