Lumbar Stenosis, FamilialNCT04124627
Place of Ultrasound Guidance of Surgery Site in Surgery for Lumbar Canal Stenosis and Lumbar Disc Herniations
A study testing Ultrasound guidance in addition to radiographic guidance in people with Lumbar Stenosis, Familial, run by Centre Medico-Chirurgicale et Obstetrique Cote d'Opale at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Stenosis, Familial
- What is being tested?
- Ultrasound guidance in addition to radiographic guidance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2019to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major patients
- Patients who gave their consent
- Patients requiring surgery for the treatment of lumbar stenosis or lumbar disc herniation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Centre MCO Côte d'Opale
Boulogne-sur-Mer, Pas De Calais, 62222
Laura Lecuyer, +33 7 61 83 90 30
Gilbert Dechambenoit, Pr
About this study
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.
Read more
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
- Being tested
- Ultrasound guidance in addition to radiographic guidance
- Keywords
- Ultrasound guidance, surgery for lumbar spine, irradiation, wrong site surgery
- Medical subject headings
- Lumbar Stenosis, Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guidance in addition to radiographic guidanceProcedure or surgery
Patients that will be operated will receive ultrasound guidance in addition to radiographic guidance, that is gold standard
| Study group | Role | What they receive |
|---|---|---|
| Single arm study | Experimental | Ultrasound plus radiographic guidance Receives: Procedure: Ultrasound guidance in addition to radiographic guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
concordance of the operating site after radiological and ultrasound guidance
ok / not ok
Measured: day 1
Secondary outcomes (3)
number of shots made and preventable
number
Measured: day 0
preventable radiation dose
Gys
Measured: day 0
exam costs (based on national cost scale)
euros
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start1 Dec 2019 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Stenosis, FamilialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Medico-Chirurgicale et Obstetrique Cote d'Opale
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04124627
- Sponsor's protocol ID
- ULTRALUMBAR
- Status last verified
- Oct 2019
- First submitted
- 10 Oct 2019
- Last updated
- 17 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Place of Ultrasound Guidance of Surgery Site in Surgery for Lumbar Canal Stenosis and Lumbar Disc Herniations
- ClinicalTrials.gov ID
- NCT04124627
- Acronym / sponsor ID
- ULTRALUMBAR
- Conditions
- Lumbar Stenosis, Familial
- Keywords
- Ultrasound guidance, surgery for lumbar spine, irradiation, wrong site surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Medico-Chirurgicale et Obstetrique Cote d'OpaleResearch network
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 11 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm study | Experimental | Procedure: Ultrasound guidance in addition to radiographic guidanceUltrasound plus radiographic guidance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Major patients
- Patients who gave their consent
- Patients requiring surgery for the treatment of lumbar stenosis or lumbar disc herniation
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound guidance in addition to radiographic guidancePatients that will be operated will receive ultrasound guidance in addition to radiographic guidance, that is gold standard | Procedure or surgery | Single arm study |
Primary outcome
concordance of the operating site after radiological and ultrasound guidance
Time frame: day 1
ok / not ok
3 secondary outcomes
number of shots made and preventable
Time frame: day 0
preventable radiation dose
Time frame: day 0
exam costs (based on national cost scale)
Time frame: day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2019.
Related trials for Lumbar Stenosis, Familial
Enrolling by invitationPhase 2
124I-Evuzamitide PET/CT Imaging In Patients With Lumbar Spinal Stenosis and Carpal Tunnel Syndrome
Lumbar Spinal Stenosis, Carpal Tunnel Syndrome (CTS)
RecruitingObservational study
Analysis of Lumbar Spine Stenosis Specimens for Identification of Transthyretin Cardiac Amyloidosis
Lumbar Spinal Stenosis, Cardiac Amyloidosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guidance in addition to radiographic guidance in people with Lumbar Stenosis, Familial, run by Centre Medico-Chirurgicale et Obstetrique Cote d'Opale at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
concordance of the operating site after radiological and ultrasound guidance (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2019.