Impact of Glenosphere Size on Range of Motion in Female Patients Undergoing Reverse Shoulder Arthroplasty
Primary Purpose
Rotator Cuff Tear Arthropathy, Massive Irreparable Rotator Cuff Tear
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Glenosphere size for Reverse Shoulder Arthroplasty
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Tear Arthropathy
Eligibility Criteria
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
Sites / Locations
- Fondren Orthopedic Group, L.L.P.
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
32mm Glenosphere
36mm Glenosphere
Arm Description
The control group will receive the standard 32mm glenosphere.
The experimental group will receive a 36mm glenosphere.
Outcomes
Primary Outcome Measures
Active range of motion
Shoulder elevation, abduction, external rotation in abduction, and internal rotation
Passive range of motion
Shoulder elevation and external rotation
Secondary Outcome Measures
American Shoulder and Elbow Surgeon (ASES) Shoulder Index
Standard functional outcomes questionnaire following shoulder surgery, range 0 - 100 (highest function)
Constant-Murley Shoulder Outcome score
Standard functional outcomes questionnaire following shoulder surgery, range 0 - 100 (highest function)
Full Information
NCT ID
NCT04093804
First Posted
September 16, 2019
Last Updated
September 16, 2019
Sponsor
Fondren Orthopedic Group L.L.P.
1. Study Identification
Unique Protocol Identification Number
NCT04093804
Brief Title
Impact of Glenosphere Size on Range of Motion in Female Patients Undergoing Reverse Shoulder Arthroplasty
Official Title
Impact of Glenosphere Size on Range of Motion in Female Patients Undergoing Reverse Shoulder Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2019 (Anticipated)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondren Orthopedic Group L.L.P.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear Arthropathy, Massive Irreparable Rotator Cuff Tear
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
32mm Glenosphere
Arm Type
Active Comparator
Arm Description
The control group will receive the standard 32mm glenosphere.
Arm Title
36mm Glenosphere
Arm Type
Experimental
Arm Description
The experimental group will receive a 36mm glenosphere.
Intervention Type
Device
Intervention Name(s)
Glenosphere size for Reverse Shoulder Arthroplasty
Intervention Description
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.
Primary Outcome Measure Information:
Title
Active range of motion
Description
Shoulder elevation, abduction, external rotation in abduction, and internal rotation
Time Frame
Change from baseline (pre-operative) to 2 years follow-up
Title
Passive range of motion
Description
Shoulder elevation and external rotation
Time Frame
Change from baseline (pre-operative) to 2 years follow-up
Secondary Outcome Measure Information:
Title
American Shoulder and Elbow Surgeon (ASES) Shoulder Index
Description
Standard functional outcomes questionnaire following shoulder surgery, range 0 - 100 (highest function)
Time Frame
Change from baseline (pre-operative) to 2 years follow-up
Title
Constant-Murley Shoulder Outcome score
Description
Standard functional outcomes questionnaire following shoulder surgery, range 0 - 100 (highest function)
Time Frame
Change from baseline (pre-operative) to 2 years follow-up
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mitzi S Laughlin, PhD
Phone
713-794-3408
Email
Mitzi.Laughlin@fondren.com
Facility Information:
Facility Name
Fondren Orthopedic Group, L.L.P.
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26853756
Citation
Mollon B, Mahure SA, Roche CP, Zuckerman JD. Impact of glenosphere size on clinical outcomes after reverse total shoulder arthroplasty: an analysis of 297 shoulders. J Shoulder Elbow Surg. 2016 May;25(5):763-71. doi: 10.1016/j.jse.2015.10.027. Epub 2016 Feb 4.
Results Reference
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Impact of Glenosphere Size on Range of Motion in Female Patients Undergoing Reverse Shoulder Arthroplasty
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