Phase
Condition
Joint Injuries
Osteoarthritis
Rheumatoid Arthritis
Treatment
Catalyst CSR Total Shoulder System
Clinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion 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
Exclusion Criteria
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)
Study Design
Study Description
Connect with a study center
Beaumont Hospital Royal Oak
Royal Oak, Michigan 48073
United StatesActive - Recruiting
Kaiser Permanente Northwest Center for Health Research
Portland, Oregon 97227
United StatesActive - Recruiting
Lifespan/University Orthopedics
Providence, Rhode Island 02914
United StatesActive - Recruiting
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