Outcomes and Safety Study of FX Shoulder Replacement Devices Tracking Patients for Up to 10 Years After Surgery

What this Trial Is About

This research aims to evaluate patient outcomes following shoulder replacement surgery using FX Shoulder Solutions medical devices. The study observes patients who have received these legally marketed devices in the USA to assess their safety, effectiveness, and long-term survivorship. The registry collects data to support regulatory requirements and share findings through presentations and publications. Participants are those implanted with FX Shoulder Solutions shoulder replacement devices, including various systems like Humelock II and Easytech Anatomical Shoulder System. The registry tracks these patients from surgery onward, with key follow-ups at 2 years to assess clinical success and up to 10 years to monitor device survivorship. Success is defined by measures such as improved shoulder function, no device migration, no revision surgery, and absence of serious device-related adverse events. During the study, patients undergo evaluations at multiple time points including 6 weeks, 3, 6, 12, and 24 months post-surgery using standardized scores like Adjusted Constant Score, QuickDASH, and Visual Analog Scale. Radiographic reviews, range of motion assessments, and tracking of adverse events and secondary surgeries occur up to 5 years. The study involves ongoing monitoring to understand the long-term performance and safety of the shoulder replacement devices.

FX Shoulder Prospective Clinical Study