Internal Fixation of Hip Fractures Using Intraoperative Simultaneous Two Axis View

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2012 by Meir Medical Center
Sponsor:
Collaborator:
Clalit Health Services
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01524718
First received: January 10, 2012
Last updated: September 2, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Fracture Neck of Femur
Radiation: Imaging with two X-ray image intensifiers

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Time of surgery [ Time Frame: 5 hours - operation time ] [ Designated as safety issue: Yes ]
    time of operation


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
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)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with intertrochanteric femoral fracture who are going to be operated by closed reduction and internal fixation with an intramedullary nail.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01524718

Contacts
Contact: Yaron Shagra Brin, MD +97297472549 yaronbrin@gmail.com
Contact: Ezequiel Palmanovich, MD ezepalm@gmail.com

Locations
Israel
Meir Medical Center Not yet recruiting
Kfar - Saba, Israel, 44281
Contact: Yaron Shagra Brin, MD       yaronbrin@gmail.com   
Contact: Ezequiel Palmanovich, MD       ezepalm@gmail.com   
Principal Investigator: Yaron Shagra Brin, MD         
Sub-Investigator: Ezequiel Palmanovich, MD         
Sponsors and Collaborators
Meir Medical Center
Clalit Health Services
  More Information

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01524718     History of Changes
Other Study ID Numbers: MMC-twoaxis-001.il
Study First Received: January 10, 2012
Last Updated: September 2, 2012
Health Authority: Israel: Ministry of Health
United States: Institutional Review Board

Keywords provided by Meir Medical Center:
radiation
time surgery

Additional relevant MeSH terms:
Femoral Neck Fractures
Fractures, Bone
Hip Fractures
Femoral Fractures
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on August 18, 2014