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Internal Fixation of Hip Fractures Using Intraoperative Simultaneous Two Axis View

NCT ID: NCT01524718

Last Updated: 2012-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Fracture Neck of Femur

Keywords

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radiation time surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Imaging with two X-ray image intensifiers

Intervention Type RADIATION

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

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Imaging with two X-ray image intensifiers

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

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clalit Health Services

OTHER

Sponsor Role collaborator

Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Meir Medical Center

Kfar Saba, , Israel

Site Status

Countries

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Israel

Central Contacts

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Yaron Shagra Brin, MD

Role: CONTACT

Phone: +97297472549

Email: [email protected]

Ezequiel Palmanovich, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Yaron Shagra Brin, MD

Role: primary

Ezequiel Palmanovich, MD

Role: backup

Other Identifiers

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MMC-twoaxis-001.il

Identifier Type: -

Identifier Source: org_study_id