RECRUITING

Catalyst CSR Shoulder System for Semi or Total Shoulder Arthroplasty

Conditions

Osteoarthritis Shoulder Avascular Necrosis of the Head of Humerus Rheumatoid Arthritis Shoulder Osteoarthritis Avascular Necrosis Rheumatoid Arthritis Post-traumatic Arthritis Correction of functional deformity

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-07-22

Study Completion:2026-02-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04968405

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 * 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)	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion 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
* 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)

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Contact

Robin Waite, RN

CONTACT

3522817747

rwaite@catalystortho.com

Principal Investigator

J. Michael Wiater, MD

PRINCIPAL_INVESTIGATOR

Beaumont Hospital Royal Oak

Study Locations (Sites)

Beaumont Hospital Royal Oak

Royal Oak, Michigan, 48073

United States

Kaiser Permanente Northwest Center for Health Research

Portland, Oregon, 97227

United States

Lifespan/University Orthopedics

Providence, Rhode Island, 02914

United States

Collaborators and Investigators

Sponsor: Catalyst OrthoScience

J. Michael Wiater, MD, PRINCIPAL_INVESTIGATOR, Beaumont Hospital Royal Oak

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-22

Study Completion Date2026-02-28

Study Record Updates

Study Start Date2022-07-22

Study Completion Date2026-02-28

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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