AETOS Shoulder System Post Market Clinical Investigation
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
∙ Patients must meet all the following criteria to be included in the study:
• Patient is at least 18 years of age at the time of consent and skeletally mature.
• 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.
• 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.
• Patient is geographically stable and willing to return to the study site for all follow-up visits.
• Patient has been adequately informed of risks and requirements of the study and is willing and able to provide informed consent for participation.
• \-