Internal Fixation of Hip Fractures Using Intraoperative Simultaneous Two Axis View

Study Overview
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Brief Summary
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Hip fractures are one of the most frequent operated fractures procedures in orthopedics, with a world wide annual incidence of approximately 1.7 million. These fractures are associated with substantial morbidity and mortality. As populations age and life expectancy increases worldwide, the incidence of these fractures is likely to raise, expected to triple in the next 50 years. The use of fluoroscopy and resultant exposure to radiation, is an integral part of surgical procedures aiming to reduce and fixate the fractured femur. The risk of contracting cancer is significantly higher for an orthopedic surgeon as Hip surgery is a major slice of the total radiation dose. Optimal positioning and control of the imaging intensifier device may result in significant reduction of radiation dose and time and in substantial shortening of the procedure. The investigators hypothesis is that this technique would substantially shorten procedure time and reduce unnecessary radiation exposure for both the patient and the medical staff. Furthermore, by using this technique the investigators can eliminate the need for fluoroscopy technician during the surgery, as there is no need to alternate fluoroscopy views.

Conditions
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Fracture Neck of Femur

Intervention / Treatment
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* Radiation: Imaging with two X-ray image intensifiers


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with intertrochanteric femoral fracture who are going to be operated by closed reduction and internal fixation with an intramedullary nail.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Imaging with two X-ray image intensifiers<br>There is no change in the procedure except for the imaging technique, while in the first group the X- ray image intensifier serves in the two planes, and being moved from one plane to the other, and in the second group the two devices are static in the same position, one in the AP plane and the other as the axial plane. | Radiation: Imaging with two X-ray image intensifiers<br>* Two fluoroscopy apparatus one in the AP plane and the other as the axial plane.<br>|
| No Intervention: Imaging with one X-ray image intensifier.<br>The X- ray image intensifier serves in the two planes, and being moved from one plane to the other | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of surgery | time of operation | 5 hours - operation time | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| X-ray time during surgery | radiation time | 5 hours - operation time | 
| Accuracy of nail position |  | 5 hours - operation time | 
| Accuracy of reduction |  | 5 hours - operation time | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radiation, time surgery