Robotic Assisted Vertebral Body Augmentation - a Radiatio... | NCT01269359

Studies
Robotic Assisted Vertebral Body Augmentation - a Radiation Reduction Tool

NCT01269359

Sponsor

Hadassah Medical Organization

Status

Unknown status

Last Update Posted

Mar 22, 2013Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Vertebral Body Augmentation

Interventions

robotic assisted surgery

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jan 3, 2011

First Submission Date that Met QC Criteria

Jan 3, 2011

First Posted Date

Jan 4, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 21, 2013

Last Update Posted Date

Mar 22, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
radiation			Procedure: robotic assisted surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
robotic assisted surgery	Procedure	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
amount of radiation	amount of radiation is calculated from the DLP (Dose Length Product)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men and Women
Ages 18-85

Exclusion Criteria:

Unwillingness to participate the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

men and women that are candidates to vertebral body augmentation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Arik Tzukert, DMD	Contact	00 972 2 6776095		arik@hadassah.org.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Organizaton		Jerusalem		91120	Israel

Intervention Browse Module

MeSH Terms

ID	Term
D065287	Robotic Surgical Procedures

Ancestor Terms

ID	Term
D025321	Surgery, Computer-Assisted
D013514	Surgical Procedures, Operative
D012371	Robotics
D001331	Automation

Browse Leaves

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Browse Branches

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