Place of Ultrasound Guidance of Surgery Site in Surgery for Lumbar Canal Stenosis and Lumbar Disc Herniations
Primary Purpose
Lumbar Stenosis, Familial
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ultrasound guidance in addition to radiographic guidance
Sponsored by
About this trial
This is an interventional diagnostic trial for Lumbar Stenosis, Familial focused on measuring Ultrasound guidance, surgery for lumbar spine, irradiation, wrong site surgery
Eligibility Criteria
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
Sites / Locations
- Centre MCO Côte d'Opale
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single arm study
Arm Description
Ultrasound plus radiographic guidance
Outcomes
Primary Outcome Measures
concordance of the operating site after radiological and ultrasound guidance
ok / not ok
Secondary Outcome Measures
number of shots made and preventable
number
preventable radiation dose
Gys
exam costs (based on national cost scale)
euros
Full Information
NCT ID
NCT04124627
First Posted
October 10, 2019
Last Updated
October 15, 2019
Sponsor
Centre Medico-Chirurgicale et Obstetrique Cote d'Opale
1. Study Identification
Unique Protocol Identification Number
NCT04124627
Brief Title
Place of Ultrasound Guidance of Surgery Site in Surgery for Lumbar Canal Stenosis and Lumbar Disc Herniations
Official Title
Place of Ultrasound Guidance of Surgery Site in Surgery for Lumbar Canal Stenosis and Lumbar Disc Herniations
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2019 (Anticipated)
Primary Completion Date
December 1, 2020 (Anticipated)
Study Completion Date
December 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Medico-Chirurgicale et Obstetrique Cote d'Opale
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Stenosis, Familial
Keywords
Ultrasound guidance, surgery for lumbar spine, irradiation, wrong site surgery
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single arm study
Arm Type
Experimental
Arm Description
Ultrasound plus radiographic guidance
Intervention Type
Procedure
Intervention Name(s)
Ultrasound guidance in addition to radiographic guidance
Intervention Description
Patients that will be operated will receive ultrasound guidance in addition to radiographic guidance, that is gold standard
Primary Outcome Measure Information:
Title
concordance of the operating site after radiological and ultrasound guidance
Description
ok / not ok
Time Frame
day 1
Secondary Outcome Measure Information:
Title
number of shots made and preventable
Description
number
Time Frame
day 0
Title
preventable radiation dose
Description
Gys
Time Frame
day 0
Title
exam costs (based on national cost scale)
Description
euros
Time Frame
day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Centre MCO Côte d'Opale
City
Boulogne-sur-Mer
State/Province
Pas De Calais
ZIP/Postal Code
62222
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Lecuyer
Phone
+33 7 61 83 90 30
First Name & Middle Initial & Last Name & Degree
Gilbert Dechambenoit, Pr
12. IPD Sharing Statement
Learn more about this trial
Place of Ultrasound Guidance of Surgery Site in Surgery for Lumbar Canal Stenosis and Lumbar Disc Herniations
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