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Robotic Assisted Vertebral Body Augmentation - a Radiation Reduction Tool

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2013 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01269359
First Posted: January 4, 2011
Last Update Posted: March 22, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hadassah Medical Organization
  Purpose

Modern orthopedic and spine surgeons strive towards minimizing surgical exposure and towards increased precision in the placement of implants. This trend requires an increased use of fluoroscopic guidance, which leads to increased exposure of the patient, surgeon and the operating room staff to radiation.

Robotic assisted spine surgery is routinely performed in the authors' institution for a variety of indications such as degenerative conditions, trauma, tumors , infections and deformity correction11. The objective of this study is to compare the radiation exposure time during robotic guided vertebral body augmentation to the published results for similar surgeries.


Condition Intervention
Vertebral Body Augmentation Procedure: robotic assisted surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • amount of radiation
    amount of radiation is calculated from the DLP (Dose Length Product)


Estimated Enrollment: 100
Groups/Cohorts Assigned Interventions
radiation Procedure: robotic assisted surgery
Robotic guidance: SpineAssist™ (Mazor Surgical Technologies, Caesarea, Israel), is a bone-mounted miniature robot. It is a semi-active system offering surgical tool guidance while leaving performance of the actual surgical operation, such as the drilling, in the surgeon's hands.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
men and women that are candidates to vertebral body augmentation
Criteria

Inclusion Criteria:

  • Men and Women
  • Ages 18-85

Exclusion Criteria:

  • Unwillingness to participate the study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01269359


Contacts
Contact: Arik Tzukert, DMD 00 972 2 6776095 arik@hadassah.org.il

Locations
Israel
Hadassah Medical Organizaton Not yet recruiting
Jerusalem, Israel, 91120
Contact: Yair Barzilay       dbar@hadassah.org.il   
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

Responsible Party: Dr. Yair Barzilay, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01269359     History of Changes
Other Study ID Numbers: BARZ-003HMO-CTIL
First Submitted: January 3, 2011
First Posted: January 4, 2011
Last Update Posted: March 22, 2013
Last Verified: March 2013