Development and Validation of Intraoperative Image-quality Criteria

Completed

• Conditions: Proximal Femur Fractures
• Interventions: Procedure: ORIF

• Registration Number: NCT01660490
• Lead Sponsor: AO Clinical Investigation and Publishing Documentation

Brief Summary

An expert panel of surgeons agreed that there is not any established, standardized approach to the teaching of intraoperative imaging and that there may be practice gaps in decision making and the use of imaging among trauma surgeons.

The panel is set to initiate a consensus-based evaluation process to develop a list of criteria for assessing images and would like to validate these criteria for differentiating good quality versus poor quality images in term of reliability and accuracy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-06
• Study First Submitted QC: 2012-08-06
• Study First Posted: 2012-08-08
• Study Start: 2012-09
• Primary Completion: 2012-10
• Study Completion: 2012-12
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-18
• Last Update Posted: 2014-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Diagnosis of proximal femur fracture
• Operated between May 2010 and December 2010
• Open Reduction Internal Fixation (ORIF)
• Lateral and anteroposterior intraoperative images available

Exclusion Criteria

None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Proximal femur fractures with ORIF	ORIF	Proximal femur fractures treated with ORIF

Primary Outcome Measures

Name	Time	Method
Evaluate if C-Arm pictures can be a predictive factor for the outcome of repositioning of humerus fractures.	Intraoperatively

Trial Locations

Locations (3)

Prof. Michael Blauth; 🇦🇹 Innsbruck, Tyrol, Austria

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Universitätsspital Basel; 🇨🇭 Basel, Switzerland