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

NCT04124627 | Unknown

• 1 other identifier: ULTRALUMBAR
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Ultrasound guidance; surgery for lumbar spine; irradiation; wrong site surgery

Outcome Measures

Primary Outcomes (1)

• concordance of the operating site after radiological and ultrasound guidance

  ok / not ok

  day 1

Secondary Outcomes (3)

• number of shots made and preventable

  day 0

• preventable radiation dose

  day 0

• exam costs (based on national cost scale)

  day 0

Study Arms (1)

Single arm study

EXPERIMENTAL

Ultrasound plus radiographic guidance

Procedure: Ultrasound guidance in addition to radiographic guidance

Interventions

Ultrasound guidance in addition to radiographic guidance PROCEDURE

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

Single arm study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Major patients
• Patients who gave their consent
• Patients requiring surgery for the treatment of lumbar stenosis or lumbar disc herniation

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Medico-Chirurgicale et Obstetrique Cote d'Opale: lead

Study Sites (1)

Centre MCO Côte d'Opale

Boulogne-sur-Mer, Pas De Calais, 62222, France

Location

MeSH Terms

Conditions

Lumbar Stenosis, Familial

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: October 11, 2019
• Study Start: December 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: October 17, 2019

Record last verified: 2019-10

Locations

FR (1)