Exactech Proximal Humerus Fracture Plate System Post Market Clinical Follow-up
Purpose
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.
Conditions
- Proximal Humeral Fracture
- Fracture Dislocation
- Non-Union Fracture
Eligibility
- Eligible Ages
- Over 21 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Recruiting Locations
NYU Grossman School of Medicine
New York, New York 10016
New York, New York 10016
Contact:
718-206-6923
718-206-6923
More Details
- Status
- Recruiting
- Sponsor
- Exactech