Catalyst CSR Shoulder System for Semi or Total Shoulder Arthroplasty

Description

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

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Study Overview

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Study Details

Study overview

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.

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

Catalyst CSR Shoulder System for Semi or Total Shoulder Arthroplasty

Condition
Osteoarthritis Shoulder
Intervention / Treatment

-

Contacts and Locations

Royal Oak

Beaumont Hospital Royal Oak, Royal Oak, Michigan, United States, 48073

Portland

Kaiser Permanente Northwest Center for Health Research, Portland, Oregon, United States, 97227

Providence

Lifespan/University Orthopedics, Providence, Rhode Island, United States, 02914

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * Has a history of open surgery to index shoulder prior to treatment with the Catalyst CSR system? (history of previous arthroscopic surgery allowed)
  • * Has a full thickness rotator cuff tear diagnosed by MFI or marked posterior glenoid wear
  • * Patient is unwilling or unable to comply with the post-operative care instructions, attend follow visits per the study schedule and complete the study assessments (i.e., Pros)
  • * The patient is a non-English speaker
  • * In the opinion of the investigator, is it not in the patient's best interest to participate in this study
  • * Local or systemic infection, or osteomyelitis of the proximal humerus or scapula; if a systemic infection or a secondary remote infection is suspected or confirmed, joint replacement surgery should be delayed until infection is resolved
  • * Inadequate or malformed bone that precludes adequate support of fixation of the prosthesis
  • * Osteoporosis
  • * Neuromuscular disorders that do not allow control of the joint
  • * Chronic instability, chronic dislocation or deficient soft tissues and other support structures (e.g., brachial plexus or deltoid muscles)
  • * Vascular insufficiency
  • * Subject's age, weight or activity level cause the surgeon to expect early failure of the system
  • * The patient is unwilling to comply or unable to comply with the post-operative care instructions
  • * Alcohol, drug, substance abuse or other conditions that would affect or impair the patient from complying with post-operative instructions
  • * Patients with known sensitivity to Co-Cr-Mo alloys typically used prosthetic devices
  • * Any disease that could adversely affect the function or expected longevity of the implants (e.g., metabolic disorders)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Catalyst OrthoScience,

J. Michael Wiater, MD, PRINCIPAL_INVESTIGATOR, Beaumont Hospital Royal Oak

Study Record Dates

2026-02-28