What side effects are associated with this type of intervention?

Common treatments for Cuff Tear Arthropathy include reverse shoulder arthroplasty (RSA), which may use a larger glenosphere to increase range of motion. Known side effects of RSA can include complications such as infection, dislocation, nerve injury, and prosthetic loosening. Additionally, patients may experience pain, swelling, and limited shoulder function post-surgery. It is important to discuss these potential risks with a healthcare provider to make an informed decision.

What prior FDA approvals exist?

The FDA has approved various treatments for Cuff Tear Arthropathy, primarily focusing on surgical interventions such as reverse shoulder arthroplasty (RSA). RSA is a common procedure for this condition, and recent studies, including those on larger glenospheres, aim to improve range of motion and outcomes for patients. While specific drugs are not typically the primary treatment for Cuff Tear Arthropathy, the focus remains on surgical advancements and prosthetic improvements to enhance patient mobility and reduce pain.

What other types of research exist?

Promising novel alternatives for cuff tear arthropathy patients in 2024 include: 1) Stem cell therapy, which is being explored for its potential to regenerate damaged tissues and improve shoulder function. 2) Platelet-rich plasma (PRP) injections, which have shown some efficacy in reducing pain and improving function in musculoskeletal injuries. 3) Advanced physical therapy techniques, including eccentric and isometric exercises, which can enhance muscle strength and joint stability. 4) Customized shoulder implants using 3D printing technology, which can provide a better anatomical fit and improve range of motion.

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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

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:

Select...

I am male.

Select...

I am 18 years old or older.

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

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

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 / 5Eligibility criteria met

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 Sep 2025

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