Status:
UNKNOWN
Impact of Glenosphere Size on Range of Motion in Female Patients Undergoing Reverse Shoulder Arthroplasty
Lead Sponsor:
Fondren Orthopedic Group L.L.P.
Conditions:
Rotator Cuff Tear Arthropathy
Massive Irreparable Rotator Cuff Tear
Eligibility:
FEMALE
18+ years
Phase:
NA
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04093804
Start Date
October 1 2019
End Date
September 1 2024
Last Update
September 18 2019
Active Locations (1)
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1
Fondren Orthopedic Group, L.L.P.
Houston, Texas, United States, 77030