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

Study Overview
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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.

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

Conditions
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Surgical Procedure, Unspecified

Intervention / Treatment
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* Device: Navigation station coupled with a 3D fluoroscopy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3D fluoroscopy and navigation station<br> | Device: Navigation station coupled with a 3D fluoroscopy<br>* 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.<br>|
| Active Comparator: 2D and anatomical landmarks<br> | Device: Navigation station coupled with a 3D fluoroscopy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reading number of trips extra-pedicular or extra bone in both groups on a postoperative TDM |  | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measure radiation of the surgeon and the patient in the two groups | delivered dose and irradiation time during the duration of the intervention for the sacro-iliac screw connections, or for the establishment of two pedicle screws in spinal surgery over a 2-D amplifier | two years | 
| Show that the operative time is not increased significantly taking into account the learning curve and the benefit provided from a conventional 2-D amplifier | comparison of operating times of interventions between 3D-navigation and conventional methods | two years |