Robotic Assisted Vertebral Body Augmentation - a Radiation Reduction Tool

NCT ID: NCT01269359

Last Updated: 2013-03-22

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

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Vertebral Body Augmentation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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radiation

robotic assisted surgery

Intervention Type PROCEDURE

Robotic guidance: SpineAssistâ„¢ (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.

Interventions

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robotic assisted surgery

Robotic guidance: SpineAssistâ„¢ (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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Men and Women
* Ages 18-85

Exclusion Criteria

* Unwillingness to participate the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Hadassah Medical Organization

Locations

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Hadassah Medical Organizaton

Jerusalem, , Israel

Site Status

Countries

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Israel

Central Contacts

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Arik Tzukert, DMD

Role: CONTACT

00 972 2 6776095

Facility Contacts

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Yair Barzilay

Role: primary

Other Identifiers

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BARZ-003HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id

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