An interventional study of Glenosphere size for Reverse Shoulder Arthroplasty in Rotator Cuff Tear Arthropathy and Massive Irreparable Rotator Cuff Tear, sponsored by Fondren Orthopedic Group L.L.P.. Status unknown at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-18.
Sponsored by Fondren Orthopedic Group L.L.P. · Not applicable, Interventional, and Treatment
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.
52 studies on the registry are indexed under Rotator Cuff Tear Arthropathy; 15 are open to participants now.
This study's planned enrollment of 120 is above the median of 93 across 29 interventional studies indexed under Rotator Cuff Tear Arthropathy.
Browse Rotator Cuff Tear Arthropathy studies →Fondren Orthopedic Group L.L.P. is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The control group will receive the standard 32mm glenosphere.
Device: Glenosphere size for Reverse Shoulder Arthroplasty
The experimental group will receive a 36mm glenosphere.
Device: Glenosphere size for Reverse Shoulder Arthroplasty
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.
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
Plan to share: No
This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Rotator Cuff Tear Arthropathy→
Fondren Orthopedic Group L.L.P.