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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
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.
Fondren Orthopedic Group, L.L.P.
Houston, Texas, United States
Active range of motion
Shoulder elevation, abduction, external rotation in abduction, and internal rotation
Time frame: Change from baseline (pre-operative) to 2 years follow-up
Passive range of motion
Shoulder elevation and external rotation
Time frame: Change from baseline (pre-operative) to 2 years follow-up
American Shoulder and Elbow Surgeon (ASES) Shoulder Index
Standard functional outcomes questionnaire following shoulder surgery, range 0 - 100 (highest function)
Time frame: 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)
Time frame: Change from baseline (pre-operative) to 2 years follow-up
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