Proximal Humerus Fractures: A Retrospective Analysis (PHFx)

PROXIMAL HUMERAL FRACTURES: A Data Analysis on Patients Undergoing Open Reduction and Internal Fixation for the Surgical Management of Proximal Humeral Fractures

The purpose of this study is to evaluate preoperative objective measurements of patients with a proximal humerus fracture and operative objective measurements to determine if there is any effect to postoperative outcomes. Patients who were 18 years old or greater at the time of open reduction, internal fixation surgery were followed clinically and radiographically to determine best practice and optimal treatment and technique, risk and rate of complication, and postoperative outcomes.

Study Overview

Status

Active, not recruiting

Study Type

Observational

Enrollment (Actual)

94

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • The Orthopaedic Research & Innovation Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All eligible patients of the principal investigator receiving open reduction internal fixation of the proximal humerus for any indication at St. Elizabeth Healthcare on or after January 1, 2010 will be evaluated and included in the data analysis.

Description

Inclusion Criteria:

  1. English speaking
  2. >18 years of age
  3. open reduction internal fixation surgical management of a proximal humeral fracture

Exclusion Criteria:

  1. Non-English speaking
  2. <18 years of age
  3. Greater Tuberosity Fractures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
total operative time
Time Frame: preoperative to up to 8 years postoperative
minutes
preoperative to up to 8 years postoperative
amount of blood loss
Time Frame: preoperative to up to 8 years postoperative
mls
preoperative to up to 8 years postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Outcomes
Time Frame: preoperative to up to 8 years postoperative
American Shoulder and Elbow Surgeon score to measure shoulder function and pain. Scale of 0-100, 100 being the best possible score
preoperative to up to 8 years postoperative
Patient Outcomes
Time Frame: preoperative to up to 8 years postoperative
Simple Shoulder Test score to measure shoulder function. Scale from 0-12, 12 being the most functional.
preoperative to up to 8 years postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: R M Greiwe, MD, The Orthopaedic Research & Innovation Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2017

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

July 24, 2018

First Submitted That Met QC Criteria

August 14, 2018

First Posted (Actual)

August 20, 2018

Study Record Updates

Last Update Posted (Actual)

May 30, 2019

Last Update Submitted That Met QC Criteria

May 29, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • ORIF.002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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