FX Shoulder Solutions Retrospective / Prospective Clinical Study

Osteoarthritis Shoulder Clinical Trial

Official title: FX Shoulder Solutions Retrospective / Prospective Clinical Study

Status Recruiting

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. ;

Related Conditions & MeSH terms

• Fracture, Shoulder
• Osteoarthritis
• Osteoarthritis Shoulder
• Rotator Cuff Syndrome of Shoulder and Allied Disorders
• Shoulder Fractures

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