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

Study Overview
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Brief Summary
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The purpose of this study is to perform a prospective randomized trial among female patients undergoing reverse shoulder arthroplasty (RSA) to determine if a larger glenosphere allows greater range of motion without an impact on complications.

Detailed Description
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A current research debate is whether glenosphere size has a significant clinical impact on a patient's range of motion (ROM) following RSA. Some researchers have shown an association between increased glenosphere size and improved ROM, but no study has determined the absolute minimal motion differences that would be recognizable or beneficial by patients. This is mostly attributable to limitations such as small sample sizes as well as the fact that shoulder dynamics are multifactorial in nature. Most studies have shown an increased ROM with larger glenosphere sizes.1 Because smaller patients are often times female and receive smaller implants, female patients may be more susceptible to limited ROM. The purpose of this study is to determine if a larger glenosphere allows for greater ROM in female patients undergoing RSA.

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

Conditions
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Rotator Cuff Tear Arthropathy, Massive Irreparable Rotator Cuff Tear

Intervention / Treatment
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* Device: Glenosphere size for Reverse Shoulder Arthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female sex 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 Consent to study participation by signing the informed consent and the Protected Health Information (PHI) form (Attachment B and C) Ability to speak, read and write English Exclusion Criteria: Male sex Any impairment that would prevent answering the surveys No children or adolescents under the age of 18 years old No prisoners, pregnant women, or mentally disabled persons No Workers' Compensation cases

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study is a randomized trial consisting of female patients undergoing reverse shoulder arthroplasty for rotator cuff tear arthropathy or a massive irreparable rotator cuff tear. The experimental group will receive a 36mm glenosphere and the control group will receive the standard 32mm glenosphere. All other conditions of the surgical procedure will be identical as well as the clinical follow-up.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 32mm Glenosphere<br>The control group will receive the standard 32mm glenosphere. | Device: Glenosphere size for Reverse Shoulder Arthroplasty<br>* Two randomized study groups will be formed with the consented patients (experimental and control). All patients will undergo reverse shoulder arthroplasty by the Principal Investigator. The experimental group patients will receive a 36mm glenosphere and the control group will receive a 32mm glenosphere. All other procedures during the surgery are identical between groups.<br>|
| Experimental: 36mm Glenosphere<br>The experimental group will receive a 36mm glenosphere. | Device: Glenosphere size for Reverse Shoulder Arthroplasty<br>* Two randomized study groups will be formed with the consented patients (experimental and control). All patients will undergo reverse shoulder arthroplasty by the Principal Investigator. The experimental group patients will receive a 36mm glenosphere and the control group will receive a 32mm glenosphere. All other procedures during the surgery are identical between groups.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Active range of motion | Shoulder elevation, abduction, external rotation in abduction, and internal rotation | Change from baseline (pre-operative) to 2 years follow-up | 
| Passive range of motion | Shoulder elevation and external rotation | Change from baseline (pre-operative) to 2 years follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Shoulder and Elbow Surgeon (ASES) Shoulder Index | Standard functional outcomes questionnaire following shoulder surgery, range 0 - 100 (highest function) | Change from baseline (pre-operative) to 2 years follow-up | 
| Constant-Murley Shoulder Outcome score | Standard functional outcomes questionnaire following shoulder surgery, range 0 - 100 (highest function) | Change from baseline (pre-operative) to 2 years follow-up |