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

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

Recruiting
21 years and older
All
Phase N/A

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Overview

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

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 details
    Proximal Humeral Fracture
    Fracture Dislocation
    Non-Union Fracture

NCT05703958

Exactech

26 January 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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