Catalyst CSR Shoulder System for Semi or Total Shoulder Arthroplasty

Osteoarthritis Shoulder Clinical Trial

Official title: Analysis of the Performance and Safety of the Catalyst CSR Shoulder System - A Prospective Study

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

The purpose of this study is to assess the performance and safety of the Catalyst CSR Shoulder System in skeletally mature patients with degenerative disease of the glenohumeral joint where hemi or total shoulder arthroplasty is determined by the surgeon to be the preferred method of treatment. Patients who sign informed consent and meet the inclusion/exclusion criteria will have the Catalyst CSR Shoulder system implanted at participating sites. Data will be collected at baseline (pre-operative), perioperatively, and postoperatively at 3 months, 6 months, 12 months and 24 months. This study is expected to take 36 months to complete. ;

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Avascular Necrosis of the Head of Humerus
• Necrosis
• Osteoarthritis
• Osteoarthritis Shoulder
• Rheumatoid Arthritis Shoulder

• NCT number: NCT04968405
• Study type: Interventional
• Source: Catalyst OrthoScience
• Contact: Robin Waite, RN
• Phone: 3522817747
• Email: rwaite@catalystortho.com
• Status: Recruiting
• Phase: N/A
• Start date: July 22, 2022
• Completion date: July 28, 2025