Actively Recruiting
An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Equinoxe Proximal Humerus Fracture Plates Clinical and Radiographic Outcomes
Led by Exactech · Updated on 2024-10-24
151
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are collecting and evaluating long-term clinical outcomes to understand the safety and performance of the Equinoxe Proximal Humerus Fracture Plates over time. This observational study follows patients who have received or will receive this specific fracture plate for proximal humeral fractures, fracture dislocations, or non-union fractures. The study is sponsored by Exactech and tracks patients up to 10 years after their surgery. Participants in this study have either undergone or are scheduled for primary surgery using the Equinoxe Proximal Humerus Fracture Plate. The study involves no experimental treatments but focuses on monitoring the outcomes of this surgical implant in real-world settings. Patients agree to attend pre- and postoperative visits and be followed for up to 10 years to provide data on their recovery and implant performance. During the study, participants will be regularly assessed using several clinical scoring tools including the Smart Score, Sane Score, ASES, and Quick DASH, with evaluations approximately once per year until study completion. These assessments help measure shoulder function and patient-reported outcomes. The study also monitors safety and implant performance long term, with data collected over a period that can extend to a decade following surgery.
CONDITIONS
Brief 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 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 10 years
Participants are followed for up to 10 years after their index surgery to evaluate clinical and radiographic outcomes.
Approximately 1 visit per year
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
S
Sandrine Angibaud
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here