The purpose of this study is to demonstrate safety and efficacy of the Simpliciti Shoulder System in total shoulder arthroplasty.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
157
Total shoulder arthroplasty system
Saint Agnes Medical Center
Fresno, California, United States
Grossmont/Sharp Hospital
La Mesa, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Device Success Rate
A subject is a Patient Success at 24-months if: 1. There is NO continuous radiolucent line around the prosthesis; and 2. The adjusted Constant Score is \> 85 (successful outcome); and 3. They did not have revision surgery; and 4. They did not have a system-related serious adverse event.
Time frame: 24 months
Quality of Life
Simple Shoulder Test 1 (worse) - 12 (best)
Time frame: 24 months
Range of Motion
* Elevation in the scapula plane * Internal rotation with arm at the side * External rotation with arm at the side
Time frame: 24 months
Strength
Strength of a Specific shoulder motion as measured in pounds of force on a dynamometer machine supplied by Tornier
Time frame: 24 months
Device Parameters
Devices will be assessed to determine percentage of participants that demonstrated the following after total shoulder arthroplasty: * Migration * Osteolysis * Subsidence
Time frame: 24 months
American Shoulder and Elbow Surgeon Score
0 (worst) - 100 (best)
Time frame: 24 Months
Pain: Visual Analog Scale
0 (best) - 10 (worst)
Time frame: 24 Months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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