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NCT05703958Recruiting

Exactech Proximal Humerus Fracture Plate System Post Market Clinical Follow-up

Exactech

Start Date

4/19/2023

Completion Date

9/30/2034

Summary

The objective of this study is to collect and evaluate long-term clinical outcomes data in order to better understand the safety and performance of the Equinoxe Proximal Humerus Fracture Plates over time. This study will follow subjects for a period of up to 10 years post-surgery.

Eligibility Criteria

Age Range: 21 years to No maximum

Inclusion Criteria: * Patient is indicated to receive Equinoxe Proximal Humerus Fracture Plate or has previously underwent primary surgery with Equioxe Proximal Humerus Fracture Plate * Patient is willing to participate by complying with pre- and postoperative visit requirements * Patient is willing to agree to be followed for up to 10 years following their index surgery * Patient is willing and able to review and sign a study informed consent form Exclusion Criteria: * Osteomyelitis of the proximal humerus or scapula * Inadequate or malformed bone that precludes adequate support or fixation of the prosthesis * Patient's age, weight, or activity level would cause the surgeon to expect early failure of the system * The patient is unwilling or unable to comply with the post-operative care instructions * Alcohol, drug, or other subtance abuse * Any disease state that could adversaly affect the function or longevity of the implant * Patient is pregnant * Patient is a prisoner * Patient has a physical or mental condition that would invalidate the results

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Conditions

Proximal Humeral FractureFracture DislocationNon-Union Fracture

Locations

NYU Grossman School of Medicine

New York, New York 10016

United States