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

Completed

• Conditions: Shoulder Disease

• Registration Number: NCT03956316
• Lead Sponsor: OrthoIndy

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-15
• Primary Completion: 2015-12-22
• Study Completion: 2015-12-22
• Study First Submitted: 2019-04-10
• Status Verified: 2019-05
• Study First Submitted QC: 2019-05-17
• Last Update Submitted: 2019-05-17
• Study First Posted: 2019-05-20
• Last Update Posted: 2019-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Total shoulder arthroplasty using the Titan Modular Total Shoulder System

Exclusion Criteria

• Declining to participate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ASES	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	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	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	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	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	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).