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NCT06077942Recruiting

FX Shoulder Solutions Retrospective / Prospective Clinical Study

FX Shoulder Solutions

Start Date

12/6/2022

Completion Date

12/30/2032

Summary

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

Detailed 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.

Eligibility Criteria

Age Range: No minimum to No maximum

Inclusion Criteria: * Received an FX Shoulder Solutions replacement medical device in accordance with the Indications for Use based upon surgeons' determination and standard of care for the selected device system beginning January 1, 2018, through June 30, 2023. Exclusion Criteria: * Patient who does not meet the inclusion criteria above

Interventions

DEVICE

FX Artificial Shoulder Prosthesis

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Conditions

Rotator Cuff Syndrome of Shoulder and Allied DisordersOsteoarthritis ShoulderFracture, Shoulder

Locations

OrthoArizona

Gilbert, Arizona 85297

United States

Advanced Orthopedics Institute

The Villages, Florida 32159

United States