Sidus Stem-Free Shoulder IDE Study

Status Completed

Clinical Trial Summary

The purpose of this study is to determine if Sidus stem-free shoulder system is safe and effective when used in total shoulder replacement.

Clinical Trial Description

The primary objectives of this study are to evaluate the safety and efficacy (defined as follows) of the Sidus Stem-Free Shoulder System in unilateral primary total shoulder arthroplasty.

Safety: Will be evaluated by monitoring the frequency and incidence of device related adverse events or unanticipated adverse device effects (UADEs) in investigational subjects as well as analyzing survivorship using revision or intended revision as an endpoint.

Efficacy: Will be determined by comparing the overall pain and functional performance, survivorship and radiographic success of investigational subjects with those subjects who received the control devices. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01878253
Study type	Interventional
Source	Zimmer Biomet
Contact
Status	Completed
Phase	N/A
Start date	July 2013
Completion date	January 2019

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