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

Shoulder Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03956316
• Other study ID #: Integra TSA
• Status: Completed
• Start date: October 15, 2014
• Est. completion date: December 22, 2015

Study information

• Verified date: May 2019
• Source: OrthoIndy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 22, 2015
• Est. primary completion date: December 22, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Total shoulder arthroplasty using the Titan Modular Total Shoulder System

Exclusion Criteria:

• Declining to participate

Related Conditions & MeSH terms

• Shoulder Disease

Intervention

Device:
• Titan Modular Total Shoulder System
total shoulder arthroplasty using the Titan Modular Total Shoulder System

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
OrthoIndy	Integra LifeSciences Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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