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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis Shoulder; Avascular Necrosis of the Head of Humerus; Rheumatoid Arthritis Shoulder
• Intervention / Treatment: Device: Catalyst CSR Total Shoulder System

Detailed Description

The purpose of this study is to assess the performance and safety of the Catalyst CSR Shoulder System in skeletally mature patients with degenerative disease of the glenohumeral joint where hemi or total shoulder arthroplasty is determined by the surgeon to be the preferred method of treatment. Patients who sign informed consent and meet the inclusion/exclusion criteria will have the Catalyst CSR Shoulder system implanted at participating sites. Data will be collected at baseline (pre-operative), perioperatively, and postoperatively at 3 months, 6 months, 12 months and 24 months. This study is expected to take 36 months to complete.

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • Beaumont Hospital Royal Oak
  • Oregon
    • Portland, Oregon, United States, 97227
      • Kaiser Permanente Northwest Center for Health Research
  • Rhode Island
    • Providence, Rhode Island, United States, 02914
      • Lifespan/University Orthopedics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Single Arm; Intervention with a 510k cleared shoulder arthroplasty device

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
American Shoulder and Elbow Surgeons (ASES) Assessment Questionnaire	Change from baseline in patient reported outcome scores using the ASES	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic Assessment	Lack of radiographic evidence of osteolysis, stress shielding or lucent line formation through a minimum of 12-months post operation.	3 months, 6 months, 12 months, 24 months
Range of Motion Assessment	Change active range of motion (ROM) from baseline (preoperative)	Baseline, 3 months, 6 months, 12 months, 24 months
American Shoulder and Elbow Surgeons (ASES) Assessment Questionnaire	Change from baseline in patient reported outcome scores using the ASES	Baseline 3 months, 6 months, 12 months, 24 months
PROMIS Physical and Mental Function (PROMIS GLOBAL-10) Questionnaire	Change from baseline in patient reported outcome scores using the PROMIS	Baseline 3 months, 6 months, 12 months, 24 months
Single Assessment Numeric Evaluation (SANE)	Change from baseline in patient reported outcome scores using the SANE	Baseline 3 months, 6 months, 12 months, 24 months
Visual Analog Score (VAS) Scale	Change from baseline in patient reported outcome scores using the VAS	Baseline 3 months, 6 months, 12 months, 24 months
Patient Satisfaction Assessment	Patient Satisfaction	6, 12 and 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Safety	Report of adverse events/serious adverse event rates related to the procedure or device; Implant removal rate; Revision rate	perioperatively, 3, 6, 12 and 24 months

Collaborators and Investigators

• Sponsor: Catalyst OrthoScience
• Investigators: Principal Investigator: J. Michael Wiater, MD, Beaumont Hospital Royal Oak

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2022
• Primary Completion (Actual): February 1, 2026
• Study Completion (Actual): February 1, 2026

Study Registration Dates

• First Submitted: March 11, 2020
• First Submitted That Met QC Criteria: July 16, 2021
• First Posted (Actual): July 20, 2021

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Osteoarthritis; Rheumatoid Arthritis; Avascular Necrosis; Post-traumatic Arthritis; Correction of functional deformity
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Pathologic Processes; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Necrosis; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Osteoarthritis; Arthritis, Rheumatoid; Osteonecrosis
• Other Study ID Numbers: 1226-9272-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No