Exactech Proximal Humerus Fracture Plate System Post Market Clinical Follow-up
Recruiting now
Conditions studied: Proximal Humeral Fracture, Fracture Dislocation, Non-Union Fracture
In brief
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.
Key facts
- Study ID
- NCT05703958
- Run by
- Exactech
- People needed
- 151
- Starts
- 2023-04-19
- Expected to finish
- 2034-09-30
- Last updated by the study team
- 2024-10-24
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- NYU Grossman School of Medicine — New York, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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