Actively Recruiting
Exactech Proximal Humerus Fracture Plate System Post Market Clinical Follow-up
Led by Exactech · Updated on 2024-10-24
151
Participants Needed
1
Research Sites
597 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Exactech Proximal Humerus Fracture Plate System Post Market Clinical Follow-up
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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 substance abuse
- Any disease state that could adversely 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
NYU Grossman School of Medicine
New York, New York, United States, 10016
Actively Recruiting
Research Team
R
Rachael Craig
CONTACT
S
Sandrine Angibaud
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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