Smith & Nephew, Inc.
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
Shoulder Osteoarthritis
Shoulder Arthritis
AETOS
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 Type : | OBSERVATIONAL |
Estimated Enrollment : | 220 participants |
Official Title : | AETOS Shoulder System Post Market Clinical Investigation |
Actual Study Start Date : | 2024-03-05 |
Estimated Primary Completion Date : | 2027-08-30 |
Estimated Study Completion Date : | 2030-08-30 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
California Pacific Orthopedics
San Francisco, California, United States, 94118
RECRUITING
Western Orthopaedics
Denver, Colorado, United States, 80210
RECRUITING
Hughston Foundation
Columbus, Georgia, United States, 31909
RECRUITING
Center for Orthopedics and Neurosurgical Care
Bend, Oregon, United States, 97701
RECRUITING
Rothman Institute
Philadelphia, Pennsylvania, United States, 19107