Evaluation of an 3D Imaging Intensifier Coupled to a Navigation Station in the Surgery of the Spine and Pelvis

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-07-31

Brief Summary

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The purpose of this study is to demonstrate an optimization of the establishment of orthopedic implants in surgery of the spine and pelvic ring by combining 3D fluoroscopy and navigation system versus conventional method involving anatomical landmarks and 2D fluoroscopy.

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Detailed Description

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Conditions

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Surgical Procedure, Unspecified

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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3D fluoroscopy and navigation station

Group Type EXPERIMENTAL

Navigation station coupled with a 3D fluoroscopy

Intervention Type DEVICE

After randomization, patients will be operated with the conventional method either with navigation station. In the conventional method, the orthopedic surgeon based on anatomical criteria to establish its implants. It uses an image intensifier in 2D mode to monitor the implementation of the implants. In computer assisted surgery, the surgeon uses a navigation station that allows real-time flow instruments to guide its implementation of the implants. It uses an image intensifier in 3D mode on the one hand to achieve a first series of image that will be used for navigation and also to monitor the implementation of the implants.

2D and anatomical landmarks

Group Type ACTIVE_COMPARATOR

Navigation station coupled with a 3D fluoroscopy

Intervention Type DEVICE

After randomization, patients will be operated with the conventional method either with navigation station. In the conventional method, the orthopedic surgeon based on anatomical criteria to establish its implants. It uses an image intensifier in 2D mode to monitor the implementation of the implants. In computer assisted surgery, the surgeon uses a navigation station that allows real-time flow instruments to guide its implementation of the implants. It uses an image intensifier in 3D mode on the one hand to achieve a first series of image that will be used for navigation and also to monitor the implementation of the implants.

Interventions

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Navigation station coupled with a 3D fluoroscopy

After randomization, patients will be operated with the conventional method either with navigation station. In the conventional method, the orthopedic surgeon based on anatomical criteria to establish its implants. It uses an image intensifier in 2D mode to monitor the implementation of the implants. In computer assisted surgery, the surgeon uses a navigation station that allows real-time flow instruments to guide its implementation of the implants. It uses an image intensifier in 3D mode on the one hand to achieve a first series of image that will be used for navigation and also to monitor the implementation of the implants.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient aged over 18 years old
* Patient affiliated to social security or similarly regime
* Patient with a disease of the pelvic ring, with an indication of establishment of a screw sacro-iliac
* Patient with a disease of the spine, with an indication of establishment of pedicle implant

Exclusion Criteria

* Intubated patient resuscitation
* Pregnant women and lactating mothers
* Adult unable to express their consent
* Ward of court or under guardianship
* Person under legal protection
* Person deprived of freedom by judicial or administrative decision
* Person hospitalized without their consent

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No