Long Term Sidus PMCF

Status Withdrawn

Clinical Trial Summary

The objectives of this study are to assess the safety and performance of the Sidus Stem-Free Shoulder Arthroplasty System in unilateral primary total shoulder arthroplasty.

Clinical Trial Description

The data collected from this study will serve the purpose of assessing safety and performance of the Sidus Shoulder. Safety: Will be assessed by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), and unanticipated adverse device effects (UADE). Performance: Will be determined by analyzing the implant survival, overall pain and functional performances (based on the ASES Patient Questionnaire and range of motion) and radiographic parameters of subjects who received the Sidus Shoulder. Implant survival will be based on removal or intended removal and determined using the observed component years (OCY) model as it is not anticipated that there will be adequate data at the 10 years follow-up to support Kaplan-Meier survivorship analysis. In the instance that there is sufficient data to perform Kaplan-Meier analysis, the analysis will be performed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04063943
Study type	Interventional
Source	Zimmer Biomet
Contact
Status	Withdrawn
Phase	N/A
Start date	July 12, 2019
Completion date	March 31, 2020

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