Development and Validation of Intraoperative Image-quality Criteria

Development and Validation of Intraoperative Image-quality Criteria A Retrospective Multicenter Case Series to Validate a Set of Intraoperative Image-quality Criteria

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.

Study Overview

• Status: Completed
• Conditions: Proximal Femur Fractures
• Intervention / Treatment: Procedure: ORIF

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Austria
  • Tyrol
    • Innsbruck, Tyrol, Austria, 6020
      • Prof. Michael Blauth
• Switzerland
  • Basel, Switzerland, 4031
    • Universitätsspital Basel
• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients with a proximal femur fractures treated with ORIF between May 2010 and December 2010

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Proximal femur fractures with ORIF; Proximal femur fractures treated with ORIF	Procedure: ORIF; Open reduction internal fixation of the proximal femur

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: AO Clinical Investigation and Publishing Documentation
• Investigators: Principal Investigator: Michael Blauth, Professor, Medical University Innsbruck

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: August 6, 2012
• First Submitted That Met QC Criteria: August 6, 2012
• First Posted (Estimate): August 8, 2012

Study Record Updates

• Last Update Posted (Estimate): March 19, 2014
• Last Update Submitted That Met QC Criteria: March 18, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Femoral Fractures; Intraoperative Care; Femoral Neck Fractures; Radiographic Image Enhancement,; Hip Fractures, Internal Fixators; Fracture Fixation Internal; Fracture Fixation Intramedullary; Fractures Bone
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures
• Other Study ID Numbers: IO Image Quality