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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up perioperatively, 3, 6, 12 and 24 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ perioperatively, 3, 6, 12 and 24 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

American Shoulder and Elbow Surgeons (ASES) Assessment Questionnaire

PROMIS Physical and Mental Function (PROMIS GLOBAL-10) Questionnaire

Patient Satisfaction Assessment

+4 more

Other outcome measures

Patient Safety

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single ArmExperimental Treatment1 Intervention

Intervention with a 510k cleared shoulder arthroplasty device

0 / 2Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruiting still open for this medical experiment?

"According to the clinicaltrials.gov page, this medical trial is actively searching for new participants, with postings dating back to July 22nd 2022 and recent updates on September 21st of the same year."

Answered by AI

How many volunteers have been recruited to participate in this experiment?

"Catalyst OrthoScience, the study's sponsor, requires 90 individuals who meet their inclusion criteria to complete this trial. This research will be conducted at Beaumont Hospital Royal Oak in Michigan and Lifespan/University Orthopedics in Rhode island."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Catalyst CSR Shoulder System for Semi or Total Shoulder Arthroplasty

2022. "Catalyst CSR Shoulder System for Semi or Total Shoulder Arthroplasty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04968405.

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