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

October 15, 2019 updated by: Centre Medico-Chirurgicale et Obstetrique Cote d'Opale

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Pas De Calais
      • Boulogne-sur-Mer, Pas De Calais, France, 62222
        • Centre MCO Côte d'Opale
        • Contact:
          • Laura Lecuyer
          • Phone Number: +33 7 61 83 90 30
        • Principal Investigator:
          • Gilbert Dechambenoit, Pr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single arm study
Ultrasound plus radiographic guidance
Procedure: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Medico-Chirurgicale et Obstetrique Cote d'Opale

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2019

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

October 10, 2019

First Submitted That Met QC Criteria

October 10, 2019

First Posted (Actual)

October 11, 2019

Study Record Updates

Last Update Posted (Actual)

October 17, 2019

Last Update Submitted That Met QC Criteria

October 15, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ULTRALUMBAR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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