Catalyst CSR Shoulder System for Semi or Total Shoulder Arthroplasty

NCT04968405 | Completed FDA Device

• 1 other identifier: 1226-9272-01
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 3

Brief 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

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

Keywords

Osteoarthritis; Avascular Necrosis; Rheumatoid Arthritis; Post-traumatic Arthritis; Correction of functional deformity

Outcome Measures

Primary Outcomes (1)

• American Shoulder and Elbow Surgeons (ASES) Assessment Questionnaire

  Change from baseline in patient reported outcome scores using the ASES

  12 Months

Secondary Outcomes (7)

• Radiographic Assessment

  3 months, 6 months, 12 months, 24 months

• Range of Motion Assessment

  Baseline, 3 months, 6 months, 12 months, 24 months

• American Shoulder and Elbow Surgeons (ASES) Assessment Questionnaire

  Baseline 3 months, 6 months, 12 months, 24 months

• PROMIS Physical and Mental Function (PROMIS GLOBAL-10) Questionnaire

  Baseline 3 months, 6 months, 12 months, 24 months

• Single Assessment Numeric Evaluation (SANE)

  Baseline 3 months, 6 months, 12 months, 24 months

Other Outcomes (1)

• Patient Safety

  perioperatively, 3, 6, 12 and 24 months

Study Arms (1)

Single Arm

OTHER

Intervention with a 510k cleared shoulder arthroplasty device

Device: Catalyst CSR Total Shoulder System

Interventions

Catalyst CSR Total Shoulder System DEVICE

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.

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Catalyst OrthoScience: lead

Study Sites (3)

Beaumont Hospital Royal Oak

Royal Oak, Michigan, 48073, United States

Location

Kaiser Permanente Northwest Center for Health Research

Portland, Oregon, 97227, United States

Location

Lifespan/University Orthopedics

Providence, Rhode Island, 02914, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Osteonecrosis; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• J. Michael Wiater, MD

  Beaumont Hospital Royal Oak

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Catalyst CSR Shoulder System

Study Record Dates

• First Submitted: March 11, 2020
• First Posted: July 20, 2021
• Study Start: July 22, 2022
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

US (3)