Robotic Assisted Vertebral Body Augmentation - a Radiation Reduction Tool
1 other identifier
observational
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 3, 2011
CompletedFirst Posted
Study publicly available on registry
January 4, 2011
CompletedMarch 22, 2013
March 1, 2013
January 3, 2011
March 21, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
amount of radiation
amount of radiation is calculated from the DLP (Dose Length Product)
Study Arms (1)
radiation
Interventions
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 Criteria
men and women that are candidates to vertebral body augmentation
You may qualify if:
- Men and Women
- Ages 18-85
You may not qualify if:
- Unwillingness to participate the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hadassah Medical Organizaton
Jerusalem, 91120, Israel
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 3, 2011
First Posted
January 4, 2011
Last Updated
March 22, 2013
Record last verified: 2013-03