FX Shoulder Prospective 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. ;

Study Design

Related Conditions & MeSH terms

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

Clinical Trial Details

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
Phase
Start date	March 31, 2021
Completion date	December 30, 2027

View Details

See also
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