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

C

Centre Medico-Chirurgicale et Obstetrique Cote d'Opale

Status

Unknown

Conditions

Lumbar Stenosis, Familial

Treatments

Procedure: Ultrasound guidance in addition to radiographic guidance

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT04124627
ULTRALUMBAR

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

Single arm study
Experimental group
Description:
Ultrasound plus radiographic guidance
Treatment:
Procedure: Ultrasound guidance in addition to radiographic guidance

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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