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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04124627
Enrollment
50
Registered
2019-10-11
Start date
2019-12-01
Completion date
2020-12-01
Last updated
2019-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Stenosis, Familial

Keywords

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

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.

Interventions

PROCEDUREUltrasound guidance in addition to radiographic guidance

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

Sponsors

Centre Medico-Chirurgicale et Obstetrique Cote d'Opale
Lead SponsorNETWORK

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
concordance of the operating site after radiological and ultrasound guidanceday 1ok / not ok

Secondary

MeasureTime frameDescription
number of shots made and preventableday 0number
preventable radiation doseday 0Gys
exam costs (based on national cost scale)day 0euros

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026