Place of Ultrasound Guidance of Surgery Site in Surgery for Lumbar Canal Stenosis and Lumbar Disc Herniations

Study Overview
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Brief Summary
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The identification of the operative site of lumbar ductal stenosis and lumbar disc herniation is classically done by radioscopy, thus inducing irradiation of the patient. The use of ultrasound in spine surgery is little studied and poorly mentioned in the scientific literature. However, it is commonly used for other types of scouting (especially anesthetics). Thus, in the absence of consensus and clear recommendations, some practitioners perform ultrasound scans . Methodological developments also validate the feasibility of the ultrasound approach. The double benefit of an ultrasound identification is firstly a lack of exposure to X-rays for both the patient and the operating team and secondly a lower cost than a conventional radiography. The main objective is to demonstrate the interest of the ultrasound identification of the surgical site in the intervention of lumbar ductal stenosis and lumbar disc herniations in terms of concordance of the operating site between ultrasound and fluoroscopy.

Official Title
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Place of Ultrasound Guidance of Surgery Site in Surgery for Lumbar Canal Stenosis and Lumbar Disc Herniations

Conditions
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Lumbar Stenosis, Familial

Intervention / Treatment
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* Procedure: Ultrasound guidance in addition to radiographic guidance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Major patients Patients who gave their consent Patients requiring surgery for the treatment of lumbar stenosis or lumbar disc herniation Exclusion Criteria: Pregnant or lactating women according to article L1121-5 of the CSP. Vulnerable persons according to article L1121-6 of the CSP. Major persons placed under guardianship or curatorship

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

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm study<br>Ultrasound plus radiographic guidance | Procedure: Ultrasound guidance in addition to radiographic guidance<br>* Patients that will be operated will receive ultrasound guidance in addition to radiographic guidance, that is gold standard<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| concordance of the operating site after radiological and ultrasound guidance | ok / not ok | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of shots made and preventable | number | day 0 | 
| preventable radiation dose | Gys | day 0 | 
| exam costs (based on national cost scale) | euros | day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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irradiation, Ultrasound guidance, surgery for lumbar spine, wrong site surgery