FX Shoulder Prospective Clinical Study
brief summary
Prospective Multi-Center Registry on study subjects with implanted devices marketed and legally commercialized in the USA by FX Shoulder Solutions.
detailed description
To evaluate patient outcomes following shoulder replacement with FX Shoulder Solutions medical devices and 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.
A patient is considered a success at minimum of 2 years post-operative follow-up based upon the following composite clinical success (CCS):
* Adjusted Constant Score that is ≥ 54 and improvement of ≥ 10 points from baseline * No continuous radiolucency or device migration/subsidence * No revision surgery * No serious device related adverse event
The Registry will continue to follow patients to 10 years post-operative to track survivorship.
official title
FX Shoulder Post-Market Follow-Up Clinical Study