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Prosthetic Device

Glenosphere Size in Reverse Shoulder Arthroplasty for Rotator Cuff Tears

N/A

Waitlist Available

Research Sponsored by Fondren Orthopedic Group L.L.P.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of rotator cuff tear arthropathy or a massive irreparable rotator cuff tear for which the patient has elected to undergo reverse shoulder arthroplasty

No history of prior shoulder arthroplasty

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline (pre-operative) to 2 years follow-up

Awards & highlights

Study Summary

This trial will compare outcomes of patients who receive a large or small glenosphere during RSA.

Who is the study for?

This trial is for women diagnosed with rotator cuff tear arthropathy or massive irreparable rotator cuff tears, opting for reverse shoulder arthroplasty. Participants must be able to understand and sign consent forms in English, with no prior shoulder replacements.Check my eligibility

What is being tested?

The study aims to determine if using a larger glenosphere (part of the shoulder implant) during reverse shoulder arthroplasty improves range of motion without increasing complications among female patients.See study design

What are the potential side effects?

While specific side effects are not listed, typical risks may include pain at the surgery site, infection, stiffness or difficulty moving the shoulder, and possible need for additional surgeries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am choosing to have surgery for my severe shoulder tear.

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I have never had shoulder replacement surgery.

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I am female.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline (pre-operative) to 2 years follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline (pre-operative) to 2 years follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline (pre-operative) to 2 years follow-up for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Active range of motion

Passive range of motion

Secondary outcome measures

American Shoulder and Elbow Surgeon (ASES) Shoulder Index

Constant-Murley Shoulder Outcome score

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: 36mm GlenosphereExperimental Treatment1 Intervention

The experimental group will receive a 36mm glenosphere.

Group II: 32mm GlenosphereActive Control1 Intervention

The control group will receive the standard 32mm glenosphere.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Fondren Orthopedic Group L.L.P.Lead Sponsor

4 Previous Clinical Trials

408 Total Patients Enrolled

Media Library

Glenosphere size for Reverse Shoulder Arthroplasty (Prosthetic Device) Clinical Trial Eligibility Overview. Trial Name: NCT04093804 — N/A

Cuff Tear Arthropathy Research Study Groups: 32mm Glenosphere, 36mm Glenosphere

Cuff Tear Arthropathy Clinical Trial 2023: Glenosphere size for Reverse Shoulder Arthroplasty Highlights & Side Effects. Trial Name: NCT04093804 — N/A

Glenosphere size for Reverse Shoulder Arthroplasty (Prosthetic Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04093804 — N/A

Frequently Asked Questions

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

Are any volunteers currently able to participate in this investigation?

"According to the data hosted on clinicaltrials.gov, this particular research project is not presently seeking participants; it was initially posted in October of 2019 and has been revised once since then. Nevertheless, there are 229 other trials actively recruiting right now."

Answered by AI

Recent research and studies

Journal of Shoulder and Elbow SurgeryJournal

Impact of Glenosphere Size on Clinical Outcomes After Reverse Total Shoulder Arthroplasty: An Analysis of 297 Shoulders

Mollon, Brent, Siddharth A. Mahure, Christopher P. Roche, and Joseph D. Zuckerman. 2016. “Impact of Glenosphere Size on Clinical Outcomes After Reverse Total Shoulder Arthroplasty: An Analysis of 297 Shoulders”. Journal of Shoulder and Elbow Surgery. Elsevier BV. doi:10.1016/j.jse.2015.10.027.

clinicaltrials.govStudy

Impact of Glenosphere Size on Range of Motion in Female Patients Undergoing Reverse Shoulder Arthroplasty

2019. "Impact of Glenosphere Size on Range of Motion in Female Patients Undergoing Reverse Shoulder Arthroplasty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04093804.