CClinicalTrials.gg
Status unknownNCT01524718Updated Sep 5, 2012

Internal Fixation of Hip Fractures Using Intraoperative Simultaneous Two Axis View

An interventional study of Imaging with two X-ray image intensifiers in Fracture Neck of Femur, sponsored by Meir Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-09-05.

Sponsored by Meir Medical Center · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Sep 2012), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Fracture Neck of Femur

Keywords

  • radiation
  • time surgery
03

In context

Femoral Neck Fractures

204 studies on the registry are indexed under Femoral Neck Fractures; 41 are open to participants now.

This study's planned enrollment of 60 is below the median of 100 across 140 interventional studies indexed under Femoral Neck Fractures.

Browse Femoral Neck Fractures studies →

Lead sponsor

Meir Medical Center is the lead sponsor of 389 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • RadiationImaging with two X-ray image intensifiers

    Two fluoroscopy apparatus one in the AP plane and the other as the axial plane.

06

What researchers measure

Primary outcomes

  1. Time of surgery

    time of operation

    Time frame: 5 hours - operation time

Secondary outcomes

  1. X-ray time during surgery

    radiation time

    Time frame: 5 hours - operation time

  2. Accuracy of nail position

    Time frame: 5 hours - operation time

  3. Accuracy of reduction

    Time frame: 5 hours - operation time

07

Study locations

1 site
  • Meir Medical Center
    Kfar - Saba, 44281, Israel
    • Yaron Shagra Brin, MD · Contact · yaronbrin@gmail.com
    • Ezequiel Palmanovich, MD · Contact · ezepalm@gmail.com
    • Yaron Shagra Brin, MD · Principal investigator
    • Ezequiel Palmanovich, MD · Sub investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01524718
Lead sponsor
Meir Medical Center
Collaborators
Clalit Health Services
Responsible party
Sponsor
First posted
Feb 2, 2012
Start date
Sep 2012
Primary completion
Oct 2012 (estimated)
Completion
Mar 2013 (estimated)
Last update
Sep 5, 2012

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.

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