RecruitingNot ApplicableNCT04968405

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


Sponsor

Catalyst OrthoScience

Enrollment

90 participants

Start Date

Jul 22, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating the safety and performance of the Catalyst CSR Shoulder System — an implant used in partial or total shoulder replacement surgery — in people with serious shoulder joint disease. **You may be eligible if...** - You are 18 years or older with fully developed bones - You have degenerative disease of the shoulder joint (such as osteoarthritis or rotator cuff arthropathy) that your doctor has determined requires a shoulder replacement - Your condition matches the approved uses for this specific implant system - You speak English **You may NOT be eligible if...** - You have had open (non-arthroscopic) surgery on the same shoulder before - You have a full-thickness rotator cuff tear or significant bone wear at the back of the shoulder socket - You are unwilling or unable to attend follow-up visits or complete the required assessments - Your doctor believes participation is not in your best interest Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECatalyst 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.


Locations(3)

Beaumont Hospital Royal Oak

Royal Oak, Michigan, United States

Lifespan/University Orthopedics

Providence, Rhode Island, United States

Kaiser Permanente Northwest Center for Health Research

Portland, Oregon, United States

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NCT04968405


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