AETOS Shoulder System

Status Recruiting

Clinical Trial Summary

The goal of this study is to confirm the safety and performance of the AETOS Shoulder System for USA adoption. This is a prospective, open, adaptive, non-comparative, multi-centre investigation enrolling a maximum of 220 subjects in 2 cohorts (anatomic and reverse) at up to 15 sites. No intra-study comparator group will be included, and there will be no randomization

Clinical Trial Description

This study will confirm the safety and performance of the AETOS Shoulder System in anatomic and reverse TSA. Revisions will not be enrolled into this study. The AETOS Shoulder System is manufactured by Smith & Nephew, Inc., 1450 Brooks Road Memphis, Tennessee 38116 USA, and has been 510k Cleared as of 07Jun2023; therefore, it is considered a post-market product and will be procured through normal commercial channels in the USA. The humeral stem is designed to be used for both Total Shoulder Arthroplasty (TSA) and reverse shoulder arthroplasty procedures. The humeral stems are designed with fins and a porous plasma coating to provide fixation within the proximal humeral metaphysis. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06319911
Study type	Observational
Source	Smith & Nephew, Inc.
Contact	Tammy Clark, MPH
Phone	3512269585
Email	tammy.clark@smith-nephew.com
Status	Recruiting
Phase
Start date	March 31, 2024
Completion date	August 30, 2030

View Details

See also
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