FX Shoulder Prospective Clinical Study

Osteoarthritis Shoulder Clinical Trial

Official title: FX Shoulder Post-Market Follow-Up Clinical Study

Status Recruiting

Clinical Trial Summary

Prospective Multi-Center Registry on study subjects with implanted devices marketed and legally commercialized in the USA by FX Shoulder Solutions.

Clinical Trial 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 Confidential FX Shoulder Post-Market Follow-Up Clinical Protocol Version 1.0 04 Aug 2022 9

• No continuous radiolucency or device migration/subsidence

• No revision surgery

• No serious device related adverse event

The Registry will continue to follow patients to 5 years post-operative to track survivorship. ;

Related Conditions & MeSH terms

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

• NCT number: NCT06078865
• Study type: Observational [Patient Registry]
• Source: FX Shoulder Solutions
• Contact: Ted McKittrick, BA
• Phone: 724 249-3364
• Email: tmckittrick@fxshouldersolutions.com
• Status: Recruiting
• Start date: March 31, 2021
• Completion date: December 30, 2027