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Internal Fixation of Hip Fractures Using Intraoperative Simultaneous Two Axis View

Primary Purpose

Fracture Neck of Femur

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Imaging with two X-ray image intensifiers
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fracture Neck of Femur focused on measuring radiation, time surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

  • Meir Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Imaging with two X-ray image intensifiers

Imaging with one X-ray image intensifier.

Arm Description

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.

The X- ray image intensifier serves in the two planes, and being moved from one plane to the other

Outcomes

Primary Outcome Measures

Time of surgery
time of operation

Secondary Outcome Measures

X-ray time during surgery
radiation time
Accuracy of nail position
Accuracy of reduction

Full Information

First Posted
January 10, 2012
Last Updated
September 2, 2012
Sponsor
Meir Medical Center
Collaborators
Clalit Health Services
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1. Study Identification

Unique Protocol Identification Number
NCT01524718
Brief Title
Internal Fixation of Hip Fractures Using Intraoperative Simultaneous Two Axis View
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
October 2012 (Anticipated)
Study Completion Date
March 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center
Collaborators
Clalit Health Services

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture Neck of Femur
Keywords
radiation, time surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Imaging with two X-ray image intensifiers
Arm Type
Experimental
Arm Description
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.
Arm Title
Imaging with one X-ray image intensifier.
Arm Type
No Intervention
Arm Description
The X- ray image intensifier serves in the two planes, and being moved from one plane to the other
Intervention Type
Radiation
Intervention Name(s)
Imaging with two X-ray image intensifiers
Intervention Description
Two fluoroscopy apparatus one in the AP plane and the other as the axial plane.
Primary Outcome Measure Information:
Title
Time of surgery
Description
time of operation
Time Frame
5 hours - operation time
Secondary Outcome Measure Information:
Title
X-ray time during surgery
Description
radiation time
Time Frame
5 hours - operation time
Title
Accuracy of nail position
Time Frame
5 hours - operation time
Title
Accuracy of reduction
Time Frame
5 hours - operation time

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with intertrochanteric femoral fracture who are going to be operated by closed reduction and internal fixation with an intramedullary nail.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yaron Shagra Brin, MD
Phone
+97297472549
Email
yaronbrin@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ezequiel Palmanovich, MD
Email
ezepalm@gmail.com
Facility Information:
Facility Name
Meir Medical Center
City
Kfar - Saba
ZIP/Postal Code
44281
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yaron Shagra Brin, MD
Email
yaronbrin@gmail.com
First Name & Middle Initial & Last Name & Degree
Ezequiel Palmanovich, MD
Email
ezepalm@gmail.com
First Name & Middle Initial & Last Name & Degree
Yaron Shagra Brin, MD
First Name & Middle Initial & Last Name & Degree
Ezequiel Palmanovich, MD

12. IPD Sharing Statement

Learn more about this trial

Internal Fixation of Hip Fractures Using Intraoperative Simultaneous Two Axis View

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