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Catalyst CSR Shoulder System for Semi or Total Shoulder Arthroplasty

NCT04968405 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2026-03-31

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

Catalyst CSR Total Shoulder System

The 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.

Sponsors & Collaborators

  • Catalyst OrthoScience

    lead INDUSTRY

Principal Investigators

  • J. Michael Wiater, MD · Beaumont Hospital Royal Oak

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-22
Primary Completion
2026-02-01
Completion
2026-02-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04968405 on ClinicalTrials.gov