Clinical Trials Directory

Trials / Completed

CompletedNCT04968405

Catalyst CSR Shoulder System for Semi or Total Shoulder Arthroplasty

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
87 (actual)
Sponsor
Catalyst OrthoScience · Industry
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
DEVICECatalyst CSR Total Shoulder SystemThe Catalyst CSR Shoulder System is a bone preserving total shoulder prosthesis designed for use in patients where the humeral head, neck and glenoid vault are of sufficient bone stock and there is an intact or reconstructable rotator cuff. The design requires minimal bone resection, thus giving the patient an alternative to other total shoulder designs where more bone is removed.

Timeline

Start date
2022-07-22
Primary completion
2026-02-01
Completion
2026-02-01
First posted
2021-07-20
Last updated
2026-03-31

Locations

3 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT04968405. Inclusion in this directory is not an endorsement.