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FX Shoulder Post-Market Follow-Up Clinical Study
Prospective Multi-Center Registry on study subjects with implanted devices marketed and legally commercialized in the USA by FX Shoulder Solutions.
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 * No continuous radiolucency or device migration/subsidence * No revision surgery * No serious device related adverse event The Registry will continue to follow patients to 10 years post-operative to track survivorship.
Age
All ages
Sex
ALL
Healthy Volunteers
No
OrthoArizona
Gilbert, Arizona, United States
First Settlement Orthopedics
Marietta, Ohio, United States
Orthopedics Rhode Island
Wakefield, Rhode Island, United States
Texas Orthopedic Specialists
Bedford, Texas, United States
Start Date
March 31, 2021
Primary Completion Date
December 30, 2031
Completion Date
December 30, 2031
Last Updated
February 9, 2026
600
ESTIMATED participants
FX Artificial Shoulder Prosthesis
DEVICE
Lead Sponsor
FX Shoulder Solutions
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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