FX Shoulder Solutions
Subjects implanted with the shoulder replacement medical devices manufactured by FX Shoulder Solutions and distributed by FX Shoulder Solutions.
Rotator Cuff Syndrome of Shoulder and Allied Disorders
Osteoarthritis Shoulder
Fracture, Shoulder
FX Artificial Shoulder Prosthesis
To evaluate patient outcomes following shoulder replacement with FX Shoulder Solutions medical devices To demonstrate effectiveness, safety and survivorship of FX Shoulder Solutions medical devices To provide data and analysis to FX Shoulder Solutions to meet regulatory requirements. To provide data and analysis for presentations, abstracts, publications and other public release of results. Clinical data in the Investigator's clinic notes and patient files regarding demographics, baseline medical and shoulder status, surgical procedure and implant components, and any completed postoperative clinical data will be collected retrospectively as data for the Study following signed patient consent and enrollment into the study. Each patient will be evaluated prospectively, and clinical data collected at the first baseline clinical evaluation using the protocol specified evaluations following study enrollment with successive postoperative evaluations in accordance with the postoperative intervals.
Study Type : | OBSERVATIONAL |
Estimated Enrollment : | 600 participants |
Official Title : | FX Shoulder Solutions Retrospective / Prospective Clinical Study |
Actual Study Start Date : | 2022-12-06 |
Estimated Primary Completion Date : | 2032-12-30 |
Estimated Study Completion Date : | 2032-12-30 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | |
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.
NOT YET RECRUITING
OrthoArizona
Gilbert, arizona, United States, 85297
RECRUITING
Advanced Orthopedics Institute
The Villages, Florida, United States, 32159