Could the Intraoperative Radiation Exposure (Fluoroscopy) of Percutaneous Pedicle Screw Fixation be Reduced Using an Electronic Conductivity Device?

Study Overview
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Brief Summary
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To compare classical pedicle finder versus pedicle finder with impedancemetry on the perioperative radiation exposure of PPTLO. These two devices are already used in common practice.

Official Title
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Could the Intraoperative Radiation Exposure (Fluoroscopy) of Percutaneous Pedicle Screw Fixation be Reduced Using an Electronic Conductivity Device? A Prospective, Randomized Study

Conditions
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Fracture Fixation, Internal

Intervention / Treatment
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* Procedure: Spinal osteosynthesis with classical pedicle finder
* Procedure: Spinal osteosynthesis with pedicle finder with impedancemetry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women between 18 and 80 years-old; Patient with an indication of PPTLO for one or two segments Patient in a position to understand protocol information; Patient who received information about the protocol and who did not show opposition to participate Exclusion Criteria: History of posterior spinal fusion surgery on the spinal level concerned by the study; Morbid obesity (body mass index greater than 35 kg / m²); Major incapable (safeguard of justice, guardianship) and persons deprived of liberty. Simultaneous participation in another research protocol involving the human person

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: classical pedicle finder<br>Spinal osteosynthesis with classical pedicle finder | Procedure: Spinal osteosynthesis with classical pedicle finder<br>* Posterior thoracic and lumbar osteosynthesis with classical pedicle finder<br>|
| Experimental: pedicle finder with impedancemetry<br>Spinal osteosynthesis with pedicle finder with impedancemetry | Procedure: Spinal osteosynthesis with pedicle finder with impedancemetry<br>* Posterior thoracic and lumbar osteosynthesis with pedicle finder with impedancemetry<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose area product in cGy.cm2 (DAP) | Dose area product in cGy.cm2 (DAP) | Surgery Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation duration in seconds (measured on the fluoroscope); | Radiation duration in seconds (measured on the fluoroscope); | Surgery Day | 
| Radiation rate | Radiation rate on:1 ring carried by the surgeon (passive dosimeter),1 passive dosimeter worn at the surgeon's eye level, 1 passive dosimeter on the fluoroscope,1 active dosimeter placed on the bust of the surgeon under the lead apron | Surgery Day | 
| Path of pedicle screws extracted from fluoroscopic images | Trajectory of pedicle screws; | Day 2 after surgery | 
| Operating time in minutes. | Operating time in minutes. | Surgery Day |