Internal Fixation of Hip Fractures Using Intraoperative Simultaneous Two Axis View
Recruitment status was: Not yet recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
- Time of surgery [ Time Frame: 5 hours - operation time ] [ Designated as safety issue: Yes ]time of operation
- X-ray time during surgery [ Time Frame: 5 hours - operation time ] [ Designated as safety issue: Yes ]radiation time
- Accuracy of nail position [ Time Frame: 5 hours - operation time ] [ Designated as safety issue: Yes ]
- Accuracy of reduction [ Time Frame: 5 hours - operation time ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||March 2013|
|Estimated Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Experimental: 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.
Radiation: Imaging with two X-ray image intensifiers
Two fluoroscopy apparatus one in the AP plane and the other as the axial plane.
No Intervention: Imaging with one X-ray image intensifier.
The X- ray image intensifier serves in the two planes, and being moved from one plane to the other
Please refer to this study by its ClinicalTrials.gov identifier: NCT01524718
|Meir Medical Center|
|Kfar - Saba, Israel, 44281|