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| Name | Class |
|---|---|
| Integra LifeSciences Corporation | INDUSTRY |
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The goals of total, reverse total and hemi shoulder arthroplasty are the same, to alleviate the patient's pain and obtain a full functional recovery. This outcome depends on the surgeon's ability to reproduce normal glenohumeral anatomy including bone morphology, capsular tension and rotator cuff function. Shoulder arthroplasty has become a safe and effective treatment for various diseases of the shoulder. This study goal is to document and report the short-term functional, radiographic, and quality of life outcomes of total shoulder arthroplasty (TSA) using the titan modular shoulder system.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Titan Modular Total Shoulder System | Device | total shoulder arthroplasty using the Titan Modular Total Shoulder System |
| Measure | Description | Time Frame |
|---|---|---|
| ASES | 1. ASES: the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment
i. The ASES consists of two dimensions: pain and function (worth 50 points each). a. The ASES questionnaire is composed of both a physician-rated component and a patient-reported component. Patient questions focus on: joint pain, instability and activities of daily living. Physician questions focus on: range of motion, strength, signs and instability | two year post op |
| EQ-5D-5L | 2. EQ5D-5L: EuroQuol-5D a. The EQ5D-5L scale evaluates general health status. The EQ-5D-5L has two sections; the first section measures health status using a descriptive system (index of 5 scores) and the second section measures health status on a Visual Analog Scale. i. The EQ-5D-5L VAS outcome is measured on a 0 - 100 point scale. Optimal health status is indicated with a score of 100. ii. The EQ-5D-5L descriptive system consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is evaluated with a score of 1-5, higher scores indicate worse outcomes. 1. On each dimension, a score of 1 indicates no patient problems in that dimension, 2 indicates slight problems in that dimension, 3 indicates moderate problems in that dimension, 4 indicates severe problems in that dimension and 5 indicates extreme problems in that dimension. | two year post op |
| PENN | 3. PENN: PENN Shoulder Score
| two year post op |
| SANE |
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Inclusion Criteria:
Exclusion Criteria:
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39 subjects received total shoulder arthroplasty using the Titan Modular Total Shoulder System. 25 subjects agreed to participate in the study.
Data will not be shared.
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4. SANE: Single assessment numeric evaluation
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| two year post op |
| CS | 5. CS: Constant-Murley Score
| two year post op |
| WOOS | 6. WOOS: Western Ontario Osteoarthritis of the Shoulder index
i. WOOS is composed of 19 items scored on 100-point VAS scales. The 19 items represent four domains (6 questions for pain and physical symptoms, 5 questions for sport/recreation/work function, 5 questions for lifestyle function and 3 questions for emotional function). | two year post op |