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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
Information provided by:
Hadassah Medical Organization Identifier:
First received: January 3, 2011
Last updated: March 21, 2013
Last verified: March 2013

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.


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

Inclusion Criteria:

  • Men and Women
  • Ages 18-85

Exclusion Criteria:

  • Unwillingness to participate the study
  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 identifier: NCT01269359

Contact: Arik Tzukert, DMD 00 972 2 6776095

Hadassah Medical Organizaton Not yet recruiting
Jerusalem, Israel, 91120
Contact: Yair Barzilay   
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

Responsible Party: Dr. Yair Barzilay, Hadassah Medical Organization Identifier: NCT01269359     History of Changes
Other Study ID Numbers: BARZ-003HMO-CTIL
Study First Received: January 3, 2011
Last Updated: March 21, 2013 processed this record on September 19, 2017