Study to Confirm Safety and Performance of the AETOS Shoulder System in Primary Anatomic and Reverse Shoulder Replacement Surgery

What this Trial Is About

Researchers are evaluating the safety and performance of the AETOS Shoulder System for use in the United States. This study is an observational, prospective, open, adaptive, multi-center investigation enrolling up to 220 participants undergoing primary anatomic or reverse total shoulder arthroplasty TSA due to shoulder osteoarthritis or arthritis. The study excludes patients who have had revision surgeries and does not include a comparator group or randomization. Participants will receive the AETOS Shoulder System implant in either an anatomic or reverse configuration during elective shoulder replacement surgery. The device has been cleared for market use and is provided through normal commercial channels. The humeral stems are designed with fins and a porous plasma coating to support fixation within the proximal humerus. Two groups are studied those receiving the anatomic implant and those receiving the reverse implant. Throughout the study, participants will attend follow-up visits at 6 months, 1 year, 2 years, 3.5 years, and 5 years to assess implant survivorship and perform radiographic evaluations including bone remodeling, component positioning, and implant condition. Functional assessments such as the American Shoulder and Elbow Score, Constant Murley Score, Simple Shoulder Test, and Single Assessment Numeric Evaluation will be collected. The study aims to monitor long-term implant performance and patient outcomes over several years.

AETOS Shoulder System