AETOS Shoulder System for Shoulder Osteoarthritis and Arthritis

This study is looking at the AETOS Shoulder System, a device used in shoulder replacement surgery. It's for people aged 18 or older who are having their first shoulder replacement for conditions like rheumatoid arthritis or traumatic arthritis. The goal is to see how well the AETOS system works and how safe it is over two years. This study will enroll up to 220 people across different sites, and it's an "observational" study, meaning researchers will watch how the device performs in real-world use. The AETOS system has already been cleared for use in the USA.

Study design
This is an observational study that will enroll up to 220 participants across multiple centers. It is an open-label, non-comparative investigation.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for two years to measure how long the implant lasts.

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NCT06319911

AETOS Shoulder System

Recruiting
Not specifiedAges 18+Observational
Smith & Nephew, Inc.
~220 participants
Updated 2024-05-07 on ClinicalTrials.gov
What's tested:AETOS

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Implant Survivorship
Measured over 2 years
Shoulder Osteoarthritis
Shoulder Arthritis
5 sites across 5 states
California1
Colorado1
Georgia1
Oregon1
Pennsylvania1
  • Kolja Boese · STUDY_DIRECTOR · Smith & Nephew, Inc.

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Eligibility criteria

Inclusion

Rheumatoid arthritis, and/or
Traumatic arthritis (Post Traumatic arthritis), and/or
Non-inflammatory degenerative joint disease, and/or
Correction of functional deformity. 3. Patient is willing and able to accommodate all study-related procedures and visits detailed in the protocol \& cooperate in the standard of care post-operative therapy. 4. Patient is geographically stable and willing to return to the study site for all follow-up visits. 5. Patient has been adequately informed of risks and requirements of the study and is willing and able to provide informed consent for participation.
  • Implant Survivorship2 years

    Implant survivorship at 2 years post operatively defined as absence of device removal or revision of any component