Internal Fixation of Hip Fractures Using Intraoperative Simultaneous Two Axis View

Not Applicable

• Conditions: Fracture Neck of Femur
• Interventions: Radiation: Imaging with two X-ray image intensifiers

• Registration Number: NCT01524718
• Lead Sponsor: Meir Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-10
• Study First Submitted QC: 2012-02-01
• Study First Posted: 2012-02-02
• Status Verified: 2012-09
• Study Start: 2012-09
• Last Update Submitted: 2012-09-02
• Last Update Posted: 2012-09-05
• Primary Completion: 2012-10
• Study Completion: 2013-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• patients with intertrochanteric femoral fracture who are going to be operated by closed reduction and internal fixation with an intramedullary nail.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Imaging with two X-ray image intensifiers	Imaging with two X-ray image intensifiers	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.

Primary Outcome Measures

Name	Time	Method
Time of surgery	5 hours - operation time	time of operation

Secondary Outcome Measures

Name	Time	Method
X-ray time during surgery	5 hours - operation time	radiation time
Accuracy of reduction	5 hours - operation time
Accuracy of nail position	5 hours - operation time

Trial Locations

Locations (1)

Meir Medical Center; 🇮🇱 Kfar - Saba, Israel