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Clinical Trial Summary

Subjects implanted with the shoulder replacement medical devices manufactured by FX Shoulder Solutions and distributed by FX Shoulder Solutions.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT06077942
Study type Observational
Source FX Shoulder Solutions
Contact Ted McKittrick, BA
Phone 7242493364
Email tmckittrick@fxshouldersolutions.com
Status Recruiting
Phase
Start date December 6, 2022
Completion date December 30, 2032

See also
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