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

Lumbar Stenosis, Familial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04124627
• Other study ID #: ULTRALUMBAR
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: October 2019
• Source: Centre Medico-Chirurgicale et Obstetrique Cote d'Opale
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Lumbar Stenosis, Familial

Intervention

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

Locations

Country	Name	City	State
France	Centre MCO Côte d'Opale	Boulogne-sur-Mer	Pas De Calais

Sponsors (1)

Lead Sponsor	Collaborator
Centre Medico-Chirurgicale et Obstetrique Cote d'Opale

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	concordance of the operating site after radiological and ultrasound guidance	ok / not ok	day 1
Secondary	number of shots made and preventable	number	day 0
Secondary	preventable radiation dose	Gys	day 0
Secondary	exam costs (based on national cost scale)	euros	day 0