RecruitingNCT05703958

Exactech Proximal Humerus Fracture Plate System Post Market Clinical Follow-up

An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Equinoxe Proximal Humerus Fracture Plates Clinical and Radiographic Outcomes


Sponsor

Exactech

Enrollment

151 participants

Start Date

Apr 19, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This post-market follow-up study is collecting long-term safety and outcomes data on patients who receive or have already received the Equinoxe Proximal Humerus Fracture Plate — a surgical implant used to repair fractures at the top of the upper arm bone (humerus). The goal is to track how well the device performs in real-world patients over up to 10 years. You may be eligible if: - You are scheduled to receive the Equinoxe Proximal Humerus Fracture Plate, or you already had the surgery - You are willing to attend pre- and post-operative follow-up visits - You are willing to be followed for up to 10 years after the surgery - You are 21 years or older You may NOT be eligible if: - You have a bone infection (osteomyelitis) of the humerus or shoulder blade - Your bone quality is inadequate to support the implant - Your age, weight, or activity level would likely lead to early device failure - You are unwilling to follow post-operative care instructions - You have substance abuse issues - You have a medical condition that could affect the implant's longevity or function - You are pregnant - You are a prisoner - You have a physical or mental condition that would invalidate study results Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

NYU Grossman School of Medicine

New York, New York, United States

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NCT05703958


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