Lumbar Spinal StenosisSUIVISTENONCT04124146
Long-term Evolution of Patients Suffering From Lumbar Canal Stenosis and Supported by Minimally Invasive Surgery: SUIVISTENO
An observational study of Lumbar Spinal Stenosis, run by Centre Medico-Chirurgicale et Obstetrique Cote d'Opale.
Trial summary
describe the functional evolution of patients at more than 10 years post intervention. describe the evolution of pain, satisfaction, quality of life of patients to more than 5 years pot intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- MRI for some patients according functionnal tests results
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2019to 1 May 2021
- Phase
- Observational
- 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
Study population: Patients who have been cared for at the institution between 2006 and 2008 (cohort) will be invited to participate in the study.
Who may be able to join
- Patients operated within the institution between 2006 and 2008
- Major patient (18 years old or over).
- Francophone.
- Affiliated to a social security scheme
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
No sites are listed yet.
About this study
Official title: Long-term Evolution of Patients Suffering From Lumbar Canal Stenosis and Supported by Minimally Invasive Surgery
describe the functional evolution of patients at more than 10 years post intervention.
describe the evolution of pain, satisfaction, quality of life of patients to more than 5 years pot intervention.
Read the detailed description
Stenosis of the lumbar canal is a degenerative disorder, occurring most often in the elderly or middle aged, after 50 years. It most often results from the combination of 2 pathologies: the congenital narrowness of the lumbar canal is decompensated over time by the anatomical reorganizations generated by osteoarthritis. It is classically manifested by pain in the lower limbs, occurring almost exclusively in walking or in case of prolonged standing. This postural and dynamic character of the symptomatology is very characteristic of this pathology. The levels most often involved are L4 / L5 and L3 / L4. But, in case of extensive stenosis, other levels may be involved (L2 / L3, L5S1 or even L1 / L2).
Surgical treatment is obviously indicated from the outset in emergency situations or in cases of severe functional disability. It is most often proposed in case of failure of a complete and well-conducted medical treatment. In practice, in cases of tight canal stenosis, only a surgical operation can relieve the patient of pain and recover a normal walk.
A minimal invasive technique: lumbar recalibration, which consists of decompression of the roots of the horse's tail under a microscope without fusion, without arthrodesis, provides a short-term functional benefit, even when Grade 1 spondylisthesis exists. The interest of this technique for the patient is twofold: first aesthetic because the incision is much smaller than in the classical technique and becomes almost invisible after a few months; then and above all it is functional because, by preserving the paravertebral muscles that it allows, this procedure is less painful and allows a lift the same day and an earlier recovery activities.
Very few scientific publications compare different surgical techniques, and even fewer results are available on the long-term future of patients.
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- MRI for some patients according functionnal tests results
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI for some patients according functionnal tests resultsRadiation
Depending on the results obtained on the evaluation criteria, additional examinations could be prescribed (imaging) for subjects with an unsatisfactory functional score. There is therefore a potential change in the usual care.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Surgery more than 10 years | Patients with surgery for spinal lumbar stenosis between 2006 and 2008 will be purposed to participate to the study. Receives: Radiation: MRI for some patients according functionnal tests results |
What is being measured
The primary outcome is the main question the study is designed to answer.
sub-functional score
items VIII to XII of the Swiss Spinal Stenosis questionnaire (French version).
Measured: Month 1
Secondary outcomes (3)
Swiss Spinal Stenosis questionnaire (French version)
under scores symptoms and satisfaction of the Swiss Spinal Stenosis questionnaire (French version)
Measured: Month 1
EQ5D questionnaire
under scores satisfaction of the EQ5D questionnaire
Measured: Month 1
Scale of assessment of lower back pain, leg and when walking
VAS scale scores
Measured: Month 1
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 May 2021 (estimated)
- Study completion1 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal StenosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 100 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
- NCT04124146
- Sponsor's protocol ID
- SUIVISTENO
- Acronym
- SUIVISTENO
- 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
- Individual data sharing
- No: The source documents are the original documents, the data and the files, from which the data concerning the research participants are reported in the observation notebook. Excel file that can be opened from a password
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
- Long-term Evolution of Patients Suffering From Lumbar Canal Stenosis and Supported by Minimally Invasive Surgery
- ClinicalTrials.gov ID
- NCT04124146
- Acronym / sponsor ID
- SUIVISTENO / SUIVISTENO
- Conditions
- Lumbar Spinal Stenosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Medico-Chirurgicale et Obstetrique Cote d'OpaleResearch network
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 May 2021 (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.
describe the functional evolution of patients at more than 10 years post intervention.
describe the evolution of pain, satisfaction, quality of life of patients to more than 5 years pot intervention.
Detailed description
Stenosis of the lumbar canal is a degenerative disorder, occurring most often in the elderly or middle aged, after 50 years. It most often results from the combination of 2 pathologies: the congenital narrowness of the lumbar canal is decompensated over time by the anatomical reorganizations generated by osteoarthritis. It is classically manifested by pain in the lower limbs, occurring almost exclusively in walking or in case of prolonged standing. This postural and dynamic character of the symptomatology is very characteristic of this pathology. The levels most often involved are L4 / L5 and L3 / L4. But, in case of extensive stenosis, other levels may be involved (L2 / L3, L5S1 or even L1 / L2).
Surgical treatment is obviously indicated from the outset in emergency situations or in cases of severe functional disability. It is most often proposed in case of failure of a complete and well-conducted medical treatment. In practice, in cases of tight canal stenosis, only a surgical operation can relieve the patient of pain and recover a normal walk.
A minimal invasive technique: lumbar recalibration, which consists of decompression of the roots of the horse's tail under a microscope without fusion, without arthrodesis, provides a short-term functional benefit, even when Grade 1 spondylisthesis exists. The interest of this technique for the patient is twofold: first aesthetic because the incision is much smaller than in the classical technique and becomes almost invisible after a few months; then and above all it is functional because, by preserving the paravertebral muscles that it allows, this procedure is less painful and allows a lift the same day and an earlier recovery activities.
Very few scientific publications compare different surgical techniques, and even fewer results are available on the long-term future of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Surgery more than 10 years | – | Radiation: MRI for some patients according functionnal tests resultsPatients with surgery for spinal lumbar stenosis between 2006 and 2008 will be purposed to participate to the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have been cared for at the institution between 2006 and 2008 (cohort) will be invited to participate in the study.
Key inclusion criteria (4 listed)
- Patients operated within the institution between 2006 and 2008
- Major patient (18 years old or over).
- Francophone.
- Affiliated to a social security scheme
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 |
|---|---|---|
| MRI for some patients according functionnal tests resultsDepending on the results obtained on the evaluation criteria, additional examinations could be prescribed (imaging) for subjects with an unsatisfactory functional score. There is therefore a potential change in the usual care. | Radiation | Patients with Surgery more than 10 years |
Primary outcome
sub-functional score
Time frame: Month 1
items VIII to XII of the Swiss Spinal Stenosis questionnaire (French version).
3 secondary outcomes
Swiss Spinal Stenosis questionnaire (French version)
Time frame: Month 1
EQ5D questionnaire
Time frame: Month 1
Scale of assessment of lower back pain, leg and when walking
Time frame: Month 1
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.
- Individual participant dataSharing planned: No. The source documents are the original documents, the data and the files, from which the data concerning the research participants are reported in the observation notebook. Excel file that can be opened from a password
Related trials for Lumbar Spinal Stenosis
Not yet recruitingObservational study
Foraminal Imaging and Symptoms in Single-Level Degenerative Lumbar Stenosis
Degenerative Lumbar Spinal Stenosis, Lumbar Foraminal Stenosis
Recruiting
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis
RecruitingObservational study
MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
Lumbar Spinal Stenosis
RecruitingObservational study
Thoracic-Lumbar Arthrodesis- Implanet Jazz
Spondylolisthesis, Spinal Stenosis
Recruiting
Surgical Treatment of Adjacent Segment Stenosis
Adjacent Segment Disease, Lumbar Spinal Stenosis
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Spinal Stenosis, run by Centre Medico-Chirurgicale et Obstetrique Cote d'Opale.
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 4 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.
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?
Contact Laura Lecuyer (+33 7 61 83 70 30, llecuyer.clinconsult@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sub-functional score (time frame: Month 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.