Short-Term Outcomes of Total Shoulder Arthroplasty Using the Titan Modular Total Shoulder System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- OrthoIndy
- 入组人数
- 25
- 主要终点
- ASES
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Total shoulder arthroplasty using the Titan Modular Total Shoulder System
排除标准
- •Declining to participate
结局指标
主要结局
ASES
时间窗: two year post op
1. ASES: the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment 1. The ASES scale is intended to measure functional limitations and pain of the shoulder. 2. 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
EQ-5D-5L
时间窗: two year post op
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.
PENN
时间窗: two year post op
3. PENN: PENN Shoulder Score 1. The PENN Shoulder Score is used to assess patient self-reported levels of pain, satisfaction and function. 2. PENN is measured on a 0 - 100 point scale; higher scores indicate better outcomes. 3. 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.
SANE
时间窗: two year post op
4. SANE: Single assessment numeric evaluation 1. SANE is an outcome scale used to record the patient's self-reported function. 2. SANE is implemented on a scale of 0 - 100, 100 indicates full function (or function prior to injury) and 0 represents no function.
CS
时间窗: two year post op
5. CS: Constant-Murley Score 1. The CS score assesses functionality after the treatment of a shoulder injury. 2. CS is measured on a 0 - 100 point scale. Higher scores indicate better shoulder function. 3. 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).
WOOS
时间窗: two year post op
6. WOOS: Western Ontario Osteoarthritis of the Shoulder index 1. WOOS is a disease-specific quality of life PRO tool, developed for osteoarthritis. 2. 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).
次要结局
未报告次要终点
研究者
Troy Roberson, MD
Principal Investigator
OrthoIndy
