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Comprehensive Shoulder System Nano IDE — Nano  

Joint Disease Clinical Trial

Official title:
A Study of the Comprehensive Shoulder System With Nano Humeral Component in Total Shoulder Arthroplasty

Clinical Trial Summary

The purpose of this clinical study is to determine the safety and efficacy of the Comprehensive® Shoulder System with Nano Humeral Component in Total Shoulder Arthroplasty (TSA).

Clinical Trial Description

The purpose of this clinical investigation is to establish the safety and efficacy of the Comprehensive® Shoulder System with Nano Humeral Component in Total Shoulder Arthroplasty. Safety and efficacy of the device will be measured by collection and analysis of the following data at the two-year or greater time point (22 months post-operative or longer):

1. American Shoulder and Elbow Surgeons (ASES) Score

2. Single Assessment Numeric Evaluation (SANE)

3. Constant Score

4. Radiographic assessment of osteolysis, radiolucencies, migration, and subsidence

5. Comparison of overall adverse event rates including rates of removal/revision and other serious adverse events. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01936259
Study type Interventional
Source Zimmer Biomet
Contact
Status Completed
Phase N/A
Start date August 2013
Completion date September 27, 2019
View Details
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