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
Conditions
Proximal Humeral FractureFracture DislocationNon-Union Fracture
Locations
NYU Grossman School of Medicine
New York, New York 10016
United States