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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
Must not have
Male sex
No children or adolescents under the age of 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline (pre-operative) to 2 years follow-up
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if using a bigger ball part in shoulder replacement surgery helps female patients move their shoulders better. Female patients often get smaller parts, which might limit their shoulder movement. A larger ball might improve movement by providing a better fit and more stability.

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.
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.
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
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am male.
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I am 18 years old or older.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Active range of motion
Passive range of motion
Secondary study objectives
American Shoulder and Elbow Surgeon (ASES) Shoulder Index
Constant-Murley Shoulder Outcome score

Awards & Highlights

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

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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Reverse shoulder arthroplasty (RSA) is a common treatment for Cuff Tear Arthropathy (CTA) that involves reversing the normal ball-and-socket structure of the shoulder to improve the function of the deltoid muscle, compensating for the deficient rotator cuff. The use of a larger glenosphere in RSA can enhance this effect by increasing the range of motion and stability, which is essential for CTA patients to regain shoulder function and reduce pain.
Repetitive H-wave device stimulation and program induces significant increases in the range of motion of post operative rotator cuff reconstruction in a double-blinded randomized placebo controlled human study.

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
1 Trials studying Rotator Cuff Tears
260 Patients Enrolled for Rotator Cuff Tears

Media Library

Glenosphere size for Reverse Shoulder Arthroplasty (Prosthetic Device) Clinical Trial Eligibility Overview. Trial Name: NCT04093804 — N/A
Rotator Cuff Tears Research Study Groups: 32mm Glenosphere, 36mm Glenosphere
Rotator Cuff Tears 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
~20 spots leftby Oct 2025