Catalyst CSR Shoulder System for Semi or Total Shoulder Arthroplasty

Not Applicable

Recruiting

• Conditions: Avascular Necrosis of the Head of Humerus; Rheumatoid Arthritis Shoulder; Osteoarthritis Shoulder
• Interventions: Device: Catalyst CSR Total Shoulder System

• Registration Number: NCT04968405
• Lead Sponsor: Catalyst OrthoScience

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.

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 Timeline

• Study First Submitted: 2020-03-11
• Study First Submitted QC: 2021-07-16
• Study First Posted: 2021-07-20
• Study Start: 2022-07-22
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-20
• Primary Completion: 2026-02-28
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Catalyst CSR Total Shoulder System	Intervention with a 510k cleared shoulder arthroplasty device

Primary Outcome Measures

Name	Time	Method
American Shoulder and Elbow Surgeons (ASES) Assessment Questionnaire	12 Months	Change from baseline in patient reported outcome scores using the ASES

Secondary Outcome Measures

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

Trial Locations

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