Short-Term Outcomes of Total Shoulder Arthroplasty Using the Titan Modular Total Shoulder System

Study Overview
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Brief Summary
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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.

Official Title
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Short-Term Outcomes of Total Shoulder Arthroplasty Using the Titan Modular Total Shoulder System

Conditions
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Shoulder Disease

Intervention / Treatment
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* Device: Titan Modular Total Shoulder System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Total shoulder arthroplasty using the Titan Modular Total Shoulder System Exclusion Criteria: Declining to participate
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Titan Modular Total Shoulder System|total shoulder arthroplasty using the Titan Modular Total Shoulder System|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ASES | 1. ASES: the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment The ASES scale is intended to measure functional limitations and pain of the shoulder. ASES is a 0 - 100 point scale; higher scores indicate better outcomes. 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 The PENN Shoulder Score is used to assess patient self-reported levels of pain, satisfaction and function. PENN is measured on a 0 - 100 point scale; higher scores indicate better outcomes. The PENN consists of 3 subscales: pain (at rest, with activity, and with strenuous activity), satisfaction and function. The PENN Pain subscale is scored from 0 to 30, the PENN satisfaction subscale is scored from 0 to 10 and the PENN function subscale is scored from 0 to 60. | two year post op | 
| SANE | 4. SANE: Single assessment numeric evaluation SANE is an outcome scale used to record the patient's self-reported function. SANE is implemented on a scale of 0 - 100, 100 indicates full function (or function prior to injury) and 0 represents no function. | two year post op | 
| CS | 5. CS: Constant-Murley Score The CS score assesses functionality after the treatment of a shoulder injury. CS is measured on a 0 - 100 point scale. Higher scores indicate better shoulder function. CS is composed of four subscales: pain (15 points, based on patient report), activities of daily living (20 points, based on patient report), strength (25 points), and range of motion (40 points). | two year post op | 
| WOOS | 6. WOOS: Western Ontario Osteoarthritis of the Shoulder index WOOS is a disease-specific quality of life PRO tool, developed for osteoarthritis. WOOS is measured on a 0-1900 point scale; 1900 indicates a clinical outcome fully symptomatic of osteoarthritis and 0 indicates an asymptomatic outcome. 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 |