AETOS Shoulder System Post Market Clinical Investigation
Smith & Nephew, Inc.
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
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 f…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Patients must meet all the following criteria to be included in the study: 1. Patient is at least 18 years of age at the time of consent and skeletally mature. 2. Patient is undergoing a primary elective anatomic or reverse shoulder replacement surgery for one of the following indications: * 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…
Interventions
- DeviceAETOS
The AETOS Shoulder System will be implanted into the right or left shoulder in the anatomic or reverse configuration
Locations (5)
- California Pacific OrthopedicsSan Francisco, California
- Western OrthopaedicsDenver, Colorado
- Hughston FoundationColumbus, Georgia
- Center for Orthopedics and Neurosurgical CareBend, Oregon
- Rothman InstitutePhiladelphia, Pennsylvania