Performance Improvement Program on Imaging II

Completed

Conditions studied: Hip Fractures, Femoral Fractures, Fractures, Bone

In brief

This study consists of a retrospective and a prospective part. For each part and in each of 5 clinics, one intraoperative postimplant image (lateral view) of 25 patients with pertrochanteric fractures will be assessed by 5 surgeons per clinic. There are two assessments in the retrospective part. a) before an educational intervention, b) after the educational intervention. The evaluated images at these two timepoints are identical. In the prospective part, the surgeons apply their new knowledge from the educational intervention. They perform the positioning of the patient during the intraoperative fluoroscopy and record the image according to the teaching material. One postimplant image of each patient will be used for the evaluation. At all three timepoints of image assessment, a questionnaire with the same set of 7 criteria (Q1-Q7) for assessing the radiographs is used. The criteria refer to the content of the educational material.

Key facts

Study ID

NCT02272972

Run by

AO Clinical Investigation and Publishing Documentation

People needed

250

Starts

2014-10-01

Expected to finish

2016-05-01

Last updated by the study team

2020-08-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years and older
• Diagnosis of a pertrochanteric femoral fracture (AO 31-A1, A2, A3)
• Surgical treatment with either a Proximal Femoral Nail Antirotation (PFNA), a PFNA-II, a Dynamic Hip Screw (DHS) or a Titanium Trochanteric Fixation Nail System (TFN)
• For the prospective part of the study:
• Informed consent obtained, i.e.:
• Ability to understand the content of the patient information/Informed Consent Form
• Willingness to allow the use of health-related data (images) according to the Clinical Investigation Plan (CIP)
• Signed and dated Ethics Committee (EC)/Institutional Review Board (IRB) approved written informed consent

You may not qualify if…

• For the prospective part of the study: - Mentally handicapped patients or patients with dementia that are not able to understand the content patient information/Informed Consent Form

Where it is running

• University of Missouri Hospital and Clinics — Columbia, Missouri, United States
• Hospital of the Medical University Graz — Graz, Austria
• University Medical Centre Ljubljana — Ljubljana, Slovenia
• Cantonal Hospital Winterthur — Winterthur, Canton of Zurich, Switzerland
• Municipal Hospital Triemli — Zurich, Canton of Zurich, Switzerland

Full record on ClinicalTrials.gov

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