Retrospective Analysis on Distal Humerus Fractures

• Conditions: Distal Humerus Fracture

• Registration Number: NCT03637621
• Lead Sponsor: The Orthopaedic Research & Innovation Foundation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-07
• Study First Submitted: 2018-07-24
• Study First Submitted QC: 2018-08-14
• Study First Posted: 2018-08-20
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-23
• Last Update Posted: 2019-10-25
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
total operative time	preoperative to up to 8 years postoperative	minutes
amount of blood loss	preoperative to up to 8 years postoperative	mls

Secondary Outcome Measures

Name	Time	Method
Patient Outcomes	preoperative to up to 8 years postoperative	Simple Shoulder Test score to measure shoulder function. Scale from 0-12, 12 being the most functional.

Trial Locations

Locations (1)

The Orthopaedic Research & Innovation Foundation; 🇺🇸 Edgewood, Kentucky, United States