Retrospective Analysis on Distal Humerus Fractures ((DHFx))

Distal Humerus Fractures: A Data Analysis on Patients Undergoing Open Reduction and Internal Fixation for the Surgical Management of Distal Humeral Fractures

The purpose of this study is to evaluate preoperative objective measurements for distal humerus ORIF patients 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 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: Unknown
• Conditions: Distal Humerus Fracture
• Intervention / Treatment: Other: ORIF

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All eligible patients of the names principal investigator receiving open reduction and internal fixation of the distal 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 distal humeral fracture performed by principal investigator at St. Elizabeth Healthcare

Exclusion Criteria:

1. Non-English speaking
2. <18 years of age

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Outcomes	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	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

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

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2018
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

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): October 25, 2019
• Last Update Submitted That Met QC Criteria: October 23, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Fractures, Bone; Humeral Fractures
• Other Study ID Numbers: ORIF.003

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