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Orthopedic Implant

Catalyst CSR Shoulder System for Shoulder Osteoarthritis

N/A
Recruiting
Led By J. Michael Wiater, MD
Research Sponsored by Catalyst OrthoScience
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must be skeletally mature with degenerative disease of the glenohumeral joint where hemi or total shoulder arthroplasty
18 years of age or older
Must not have
The patient is unwilling to comply or unable to comply with the post-operative care instructions
Neuromuscular disorders that do not allow control of the joint
Timeline
Screening 3 weeks
Treatment Varies
Follow Up perioperatively, 3, 6, 12 and 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will assess the safety and effectiveness of the Catalyst CSR Shoulder System through clinical and radiographic evaluations at multiple time points over 24 months.

Who is the study for?
This trial is for adults with degenerative shoulder conditions like arthritis or necrosis who need a hemi or total shoulder arthroplasty. Candidates must be skeletally mature and fit the device's usage guidelines. Exclusions include chronic joint issues, high risk of implant failure due to weight/activity, non-compliance with care instructions, neuromuscular disorders affecting joint control, metal allergies, metabolic diseases affecting implants' longevity, osteoporosis, certain prior surgeries or rotator cuff tears.
What is being tested?
The Catalyst CSR Shoulder System is being tested in this study to assess its performance and safety through clinical and radiographic evaluations over a period of up to 24 months post-surgery. This prospective multi-center study will take place across various locations in the United States.
What are the potential side effects?
While specific side effects are not listed here, common risks associated with shoulder arthroplasty may include pain at the surgery site, infection risks around the implant area, possible allergic reactions to materials used in the system (like Co-Cr-Mo alloys), inflammation around joints or muscles affected by surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a mature skeleton with shoulder joint disease needing surgery.
Select...
I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am unable or unwilling to follow post-surgery care instructions.
Select...
I have a condition that affects my ability to control my joints.
Select...
I have long-term joint instability or muscle support issues.
Select...
My bones are not strong or shaped correctly to support an implant.
Select...
I do not have an infection in my shoulder or anywhere else.
Select...
I have poor blood flow in my vessels.
Select...
I have been diagnosed with osteoporosis.
Select...
I am willing and able to follow post-op care, attend follow-up visits, and complete study assessments.
Select...
I have a complete tear in my shoulder's rotator cuff or severe shoulder joint wear.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~perioperatively, 3, 6, 12 and 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and perioperatively, 3, 6, 12 and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
American Shoulder and Elbow Surgeons (ASES) Assessment Questionnaire
PROMIS Physical and Mental Function (PROMIS GLOBAL-10) Questionnaire
Patient Satisfaction Assessment
+4 more
Other study objectives
Patient Safety

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention
Intervention with a 510k cleared shoulder arthroplasty device

Find a Location

Who is running the clinical trial?

Catalyst OrthoScienceLead Sponsor
J. Michael Wiater, MDPrincipal InvestigatorBeaumont Hospital Royal Oak
2 Previous Clinical Trials
249 Total Patients Enrolled

Media Library

Catalyst CSR Shoulder System (Orthopedic Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04968405 — N/A
~31 spots leftby Feb 2026
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