AETOS Shoulder System
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSmith & Nephew, Inc.
About this trial
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
Eligibility criteria
Qualifiers
Patient is at least 18 years of age at the time of consent and skeletally mature.
Rheumatoid arthritis, and/or
Traumatic arthritis (Post Traumatic arthritis), and/or
Non-inflammatory degenerative joint disease, and/or
Disqualifiers
Patient has a contraindication to AETOS.
Patient is undergoing a revision shoulder replacement surgery including total or partial arthroplasty.
Patient is indicated for a Hemiarthroplasty.
Patient has traumatic injury or a fracture.
Trial design
Treatments tested in this trial
- AETOS
Treatment groups
220 Participants
are divided into 2 treatment groupsLocations
5California Pacific Orthopedics94118, San FranciscoCalifornia, United States
Western Orthopaedics80210, DenverColorado, United States
Hughston Foundation31909, ColumbusGeorgia, United States
Center for Orthopedics and Neurosurgical Care97701, BendOregon, United States
Sponsors and collaborators
Smith & Nephew, Inc.
Lead sponsor
Source ClinicalTrials.gov