Internal Fixation of Hip Fractures Using Intraoperative Simultaneous Two Axis View
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2012
CompletedFirst Posted
Study publicly available on registry
February 2, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedSeptember 5, 2012
September 1, 2012
1 month
January 10, 2012
September 2, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time of surgery
time of operation
5 hours - operation time
Secondary Outcomes (3)
X-ray time during surgery
5 hours - operation time
Accuracy of nail position
5 hours - operation time
Accuracy of reduction
5 hours - operation time
Study Arms (2)
Imaging with two X-ray image intensifiers
EXPERIMENTALThere 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.
Imaging with one X-ray image intensifier.
NO INTERVENTIONThe X- ray image intensifier serves in the two planes, and being moved from one plane to the other
Interventions
Two fluoroscopy apparatus one in the AP plane and the other as the axial plane.
Eligibility Criteria
You may qualify if:
- patients with intertrochanteric femoral fracture who are going to be operated by closed reduction and internal fixation with an intramedullary nail.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Meir Medical Centerlead
- Clalit Health Servicescollaborator
Study Sites (1)
Meir Medical Center
Kfar Saba, 44281, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2012
First Posted
February 2, 2012
Study Start
September 1, 2012
Primary Completion
October 1, 2012
Study Completion
March 1, 2013
Last Updated
September 5, 2012
Record last verified: 2012-09