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Robotic Assisted Vertebral Body Augmentation - a Radiation Reduction Tool

This study is not yet open for participant recruitment.
Verified March 2013 by Hadassah Medical Organization
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01269359
First received: January 3, 2011
Last updated: March 21, 2013
Last verified: March 2013
History of Changes
  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 [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Yair Barzilay, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01269359     History of Changes
Other Study ID Numbers: BARZ-003HMO-CTIL
Study First Received: January 3, 2011
Last Updated: March 21, 2013
Health Authority: Israel: Ministry of Health

ClinicalTrials.gov processed this record on May 19, 2013