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

NCT ID: NCT04124627

Last Updated: 2019-10-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2020-12-01

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.

Conditions

Lumbar Stenosis, Familial

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Single arm study

Ultrasound plus radiographic guidance

Group Type: EXPERIMENTAL

Ultrasound guidance in addition to radiographic guidance

Intervention Type: PROCEDURE

Patients that will be operated will receive ultrasound guidance in addition to radiographic guidance, that is gold standard

Interventions

Ultrasound guidance in addition to radiographic guidance

Patients that will be operated will receive ultrasound guidance in addition to radiographic guidance, that is gold standard

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Medico-Chirurgicale et Obstetrique Cote d'Opale

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre MCO Côte d'Opale

Boulogne-sur-Mer, Pas De Calais, France

Countries

France

Facility Contacts

Laura Lecuyer

Role: primary

+33 7 61 83 90 30

Other Identifiers

ULTRALUMBAR

Identifier Type: -

Identifier Source: org_study_id