About this trial
The purpose of this study is to determine if patients undergoing anatomic total shoulder arthroplasty (aTSA) will have improved patient reported outcome scores at 1 year compared to those undergoing reverse total shoulder arthroplasty (rTSA).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Shoulder arthritis
Intact rotator cuff
Glenoid retroversion less than 25°
Disqualifiers
Rotator cuff insufficiency
Fracture deformity/sequelae
Severe glenoid deformity (C glenoid, severe A2, B2 glenoid)
Current or previous infection of shoulder
Trial design
Parallel
Treatments tested in this trial
aTSA
Procedure/SurgeryPatients with shoulder arthritis with an intact rotator cuff that requires surgical correction will undergo anatomic total shoulder arthroplasty (aTSA) procedure.
rTSA
Procedure/SurgeryPatients with shoulder arthritis with an intact rotator cuff that requires surgical correction will undergo reverse total shoulder arthroplasty (rTSA) procedure.
Treatment groups
Trial outcomes
Primary outcomes
American Shoulder and Elbow Surgeons (ASES) Questionnaire score
The American Shoulder and Elbow Surgeons (ASES) score is a self-report survey consisting of a pain scale and activities of daily living section. Total scores range from 0 to 100, where higher scores indicate better shoulder function and less pain.
Secondary outcomes
Change in Visual Analog Scale (VAS) Score
The Visual Analog Scale (VAS) is a 1 item self-report survey that asks the subject to rate the level of pain on a scale of 0 (no pain) - 10 (worst imaginable pain).
Change in Single Assessment Numeric Evaluation (SANE) Score
The Single Assessment Numeric Evaluation (SANE) is a 2 item self-report survey that asks subjects to rate the percent of normal range on both the affected joint/region and the opposite joint/region. Scores range from 0% - 100%, with 100% indicating normal range.
Change in American Shoulder and Elbow Surgeons (ASES) Questionnaire score
The American Shoulder and Elbow Surgeons (ASES) score is a self-report survey consisting of a pain scale and activities of daily living section. Total scores range from 0 to 100, where higher scores indicate better shoulder function and less pain.
Change in Shoulder Subjective Value (SSV) Score
The Subjective Shoulder Value (SSV) is 1 item self-report survey that asks subjects to rate their overall shoulder function as a percentage of a "normal" (100%) shoulder.
Sponsors and contacts
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