Osteoarthritis ShoulderRotator Cuff Syndrome of Shoulder and Allied DisordersFracture, Shoulder
Investigational drug(s) / intervention(s)
FX Artificial Shoulder Prosthesis
FX Artificial Shoulder Prosthesis: Humelock II Anatomic Shoulder System, Humelock II Reversible Shoulder System, Humelock Reverse Shoulder System, Humeris Shoulder System, Easytech Anatomical Shoulder System, FXV135 Mini Shoulder System, FXV135 Humelock Shoulder System
Study summary
Prospective Multi-Center Registry on study subjects with implanted devices marketed and legally commercialized in the USA by FX Shoulder Solutions.
Eligibility
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria:
Receive an FX shoulder replacement medical device in accordance with the Indications for Use for the selected device system.
Exclusion Criteria:
Patient who does not meet the inclusion criteria.
Primary outcome measure(s)
A patient is considered a success at post-operative follow-up based upon the following composite clinical success (CCS): — 2 years 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.
Survivorship — 10 years Follow patient's post-operative to track survivorship.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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