Catalyst CSR Shoulder System for Semi or Total Shoulder Arthroplasty

Osteoarthritis Shoulder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04968405
• Other study ID #: 1226-9272-01
• Status: Recruiting
• Phase: N/A
• Start date: July 22, 2022
• Est. completion date: July 28, 2025

Study information

• Verified date: November 2023
• Source: Catalyst OrthoScience
• Contact: Robin Waite, RN
• Phone: 3522817747
• Email: rwaite[@]catalystortho.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: July 28, 2025
• Est. primary completion date: July 28, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Avascular Necrosis of the Head of Humerus
• Necrosis
• Osteoarthritis
• Osteoarthritis Shoulder
• Rheumatoid Arthritis Shoulder

Intervention

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.

Locations

Country	Name	City	State
United States	Kaiser Permanente Northwest Center for Health Research	Portland	Oregon
United States	Lifespan/University Orthopedics	Providence	Rhode Island
United States	Beaumont Hospital Royal Oak	Royal Oak	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Catalyst OrthoScience

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	American Shoulder and Elbow Surgeons (ASES) Assessment Questionnaire	Change from baseline in patient reported outcome scores using the ASES	12 Months
Secondary	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
Secondary	Range of Motion Assessment	Change active range of motion (ROM) from baseline (preoperative)	Baseline, 3 months, 6 months, 12 months, 24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Patient Satisfaction Assessment	Patient Satisfaction	6, 12 and 24 months