Development and Validation of Intraoperative Image-quality Criteria

Proximal Femur Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01660490
• Other study ID #: IO Image Quality
• Status: Completed
• Phase: N/A
• First received: August 6, 2012
• Last updated: March 18, 2014
• Start date: September 2012
• Est. completion date: December 2012

Study information

• Verified date: March 2014
• Source: AO Clinical Investigation and Documentation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: EthikkommissionSwitzerland: EthikkommissionUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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:

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Femoral Fractures
• Proximal Femur Fractures

Intervention

Procedure:
• ORIF
Open reduction internal fixation of the proximal femur

Locations

Country	Name	City	State
Austria	Prof. Michael Blauth	Innsbruck	Tyrol
Switzerland	Universitätsspital Basel	Basel
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
AO Clinical Investigation and Documentation

Countries where clinical trial is conducted

United States,  Austria,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate if C-Arm pictures can be a predictive factor for the outcome of repositioning of humerus fractures.		Intraoperatively	No