Analysis of the Performance and Safety of the Catalyst CSR Shoulder System - A Prospective Study
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Evaluation of the performance and safety of the Catalyst CSR Shoulder System with clinical and radiographic results at multiple time points through 24 months postoperatively This study will be a prospective multi-center study conducted in the United States.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
• 18 years of age or older
• Patient must be skeletally mature with degenerative disease of the glenohumeral joint where hemi or total shoulder arthroplasty
• Meets the Catalyst CSR Shoulder System Indications for Use according to approved labeling
Locations
United States
Michigan
Beaumont Hospital Royal Oak
RECRUITING
Royal Oak
Oregon
Kaiser Permanente Northwest Center for Health Research
RECRUITING
Portland
Rhode Island
Lifespan/University Orthopedics
RECRUITING
Providence
Contact Information
Primary
Robin Waite, RN
rwaite@catalystortho.com
3522817747
Time Frame
Start Date: 2022-07-22
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 90
Treatments
Other: Single Arm
Intervention with a 510k cleared shoulder arthroplasty device
Related Therapeutic Areas
Sponsors
Leads: Catalyst OrthoScience