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

Not Applicable

• Conditions: Lumbar Stenosis, Familial
• Interventions: Procedure: Ultrasound guidance in addition to radiographic guidance

• Registration Number: NCT04124627
• Lead Sponsor: Centre Medico-Chirurgicale et Obstetrique Cote d'Opale

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-10
• Study First Submitted QC: 2019-10-10
• Study First Posted: 2019-10-11
• Last Update Submitted: 2019-10-15
• Last Update Posted: 2019-10-17
• Study Start: 2019-12-01
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm study	Ultrasound guidance in addition to radiographic guidance	Ultrasound plus radiographic guidance

Primary Outcome Measures

Name	Time	Method
concordance of the operating site after radiological and ultrasound guidance	day 1	ok / not ok

Secondary Outcome Measures

Name	Time	Method
number of shots made and preventable	day 0	number
preventable radiation dose	day 0	Gys
exam costs (based on national cost scale)	day 0	euros

Trial Locations

Locations (1)

Centre MCO Côte d'Opale; 🇫🇷 Boulogne-sur-Mer, Pas De Calais, France