NCT06319911

AETOS Shoulder System

AETOS Shoulder System Post Market Clinical Investigation

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 220 (estimated)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Shoulder Osteoarthritis
• Shoulder Arthritis

Interventions

Type	Name	Description
DEVICE	AETOS	The AETOS Shoulder System will be implanted into the right or left shoulder in the anatomic or reverse configuration

Timeline

• Start date: 2024-03-05
• Primary completion: 2027-08-30
• Completion: 2030-08-30
• First posted: 2024-03-20
• Last updated: 2024-05-07

Locations

5 sites across 1 country: United States