Health Trials

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 group

Locations

4
University of Colorado, Anschutz School of Medicine80045, AuroraColorado, United States
Indiana Hand to Shoulder Center46260, IndianapolisIndiana, United States
Duke University Medical Center, Department of Orthopaedic Surgery27560, MorrisvilleNorth Carolina, United States
University of Texas Health San Antonio, Department of Orthopaedics78229, San AntonioTexas, United States

Sponsors and collaborators

Keri Medical SA

Lead sponsor

MCRA (an IQVIA business)

Collaborator

Source ClinicalTrials.gov