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

NCT03956316 | Completed FDA Device

• 1 other identifier: Integra TSA
• Study Type: observational
• Target: 25
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Shoulder Disease

Outcome Measures

Primary Outcomes (6)

• ASES

  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

  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 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.

  two year post op

• SANE

  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.

  two year post op

• CS

  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).

  two year post op

• WOOS

  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).

  two year post op

Interventions

Titan Modular Total Shoulder System DEVICE

total shoulder arthroplasty using the Titan Modular Total Shoulder System

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

39 subjects received total shoulder arthroplasty using the Titan Modular Total Shoulder System. 25 subjects agreed to participate in the study.

You may qualify if:

• Total shoulder arthroplasty using the Titan Modular Total Shoulder System

You may not qualify if:

• Declining to participate

Sponsors & Collaborators

• OrthoIndy: lead
• Integra LifeSciences Corporation: collaborator

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: May 20, 2019
• Study Start: October 15, 2014
• Primary Completion: December 22, 2015
• Study Completion: December 22, 2015
• Last Updated: May 20, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share