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Clinical Outcomes of the ALPS Proximal Humerus Plating System

Clinical Outcomes of the ALPS Proximal Humerus Plating System

Recruiting
18 years and older
All
Phase N/A

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Overview

The purpose of this study is to document the performance and clinical outcomes of the A.L.P.S® Proximal Humerus Plating System.

Specific Aims:

  • Conduct physical assessments measuring shoulder strength and range of motion, physician assessment of radiographs
  • Obtain patient-reported outcomes regarding pain level, function capabilities, and work/leisure restrictions
  • Document revisions, complications, and adverse events

Description

The purpose of this study is to document the performance and clinical outcomes of the A.L.P.S® Proximal Humerus Plating System.

Specific Aims:

  • Conduct physical assessments measuring shoulder strength and range of motion, physician assessment of radiographs
  • Obtain patient-reported outcomes regarding pain level, function capabilities, and work/leisure restrictions
  • Document revisions, complications, and adverse events

Eligibility

Inclusion Criteria:

  • Patients who present with a proximal humerus fracture requiring primary or revision ORIF using A.L.P.S Proximal Humerus Plating System
  • Patients who present with a proximal humerus fracture that involves the metaphysis
  • 18 years or older

Exclusion Criteria:

  • Patients under the age of 18
  • Patients who have an infection, sepsis, or osteomyelitis
  • Patients who are unwilling to take part in study, have documented psychiatric disorder that limits ability to consent and maintain follow-up, or who may have severe problems maintaining follow-up (e.g. patients who are prisoners, homeless, intellectually changed without adequate family support)
  • Patients who do not speak English (do to unavailability of non-English surveys)
  • Patients who have known risk factors of pathologic fractures (e.g. bone metastasis)
  • Patients who have received treatment for osteoporosis (e.g. bisphosphonate) within the last 5 years or whose treatment lasted longer than 5 years
  • Patients who have Type 1 diabetes
  • Patients who have other bone disease (e.g. osteogenesis imperfecta, Paget's disease, thyroid disease, Vitamin D deficiency, hyperparathyroidism)
  • Patients that have a history of cancer, abnormal serum calcium, or chronic steroid use

Study details
    Proximal Humeral Fracture

NCT03328650

Vanderbilt University Medical Center

21 March 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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