Retrospective Analysis on Distal Humerus Fractures

Distal Humerus Fracture Clinical Trial

— (DHFx)  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03637621
• Other study ID #: ORIF.003
• Status: Active, not recruiting
• Start date: January 7, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: October 2019
• Source: The Orthopaedic Research & Innovation Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Distal Humerus Fracture
• Fractures, Bone
• Humeral Fractures

Intervention

Other:
• ORIF
open reduction internal fixation of the distal humerus

Locations

Country	Name	City	State
United States	The Orthopaedic Research & Innovation Foundation	Edgewood	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
The Orthopaedic Research & Innovation Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total operative time	minutes	preoperative to up to 8 years postoperative
Primary	amount of blood loss	mls	preoperative to up to 8 years postoperative
Secondary	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
Secondary	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