Lumbar Stenosis, FamilialCLE/EOSNCT03065452
Sagittal Imbalance and Lumbar Stenosis Surgery: Decompression Without Implant
An observational study of Lumbar Stenosis, Familial, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Lumbar stenosis (LSS) is the most frequent degenerative lumbar disease and is the most frequent indication for spinal surgery. When non-invasive treatments fail, decompression surgery is the gold standard therapy for the majority of patients and generally improves symptoms. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lumbar Stenosis, Familial
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2014to May 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: consecutive patients who underwent open decompression surgery (laminotomy) were prospectively included in this study
Who may be able to join
- Symptoms and signs of neurogenic claudication and radiological signs of central lumbar stenosis;
- Patients undergoing open decompression surgery ≤ 3 levels,
- All patients with symptoms that did not respond to at least 3 months of non-invasive treatment.
Who cannot join
- Patients were excluded from the study if they had one or several of the following clinical and/or radiological criteria:
- spondylolisthesis (disc slip > 5 mm),
- criteria showing instability (variation of > 10° in the angle formed by the vertebral endplates on dynamic images).
- scoliosis (Cobb angle > 20 °).
- Patients lost to follow-up were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Lumbar stenosis (LSS) is the most frequent degenerative lumbar disease and is the most frequent indication for spinal surgery. When non-invasive treatments fail, decompression surgery is the gold standard therapy for the majority of patients and generally improves symptoms.
However, few studies have investigated the improvement in posture (radiological parameters) after surgery. In lumbar stenosis, patients may present a forward leaning posture (to relieve pain), which is responsible for sagittal imbalance.
The aim of this prospective study was to evaluate the repercussions of decompression surgery on sagittal balance and to compare these with aux clinical results. investigators included patients operated on for isolated lumbar canal stenosis.
- Conditions
- Lumbar Stenosis, Familial
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Patients who underwent open decompression surgery | Observational study on patients who underwent open decompression surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vertical sagittal axis
Evaluation of sagittal parameters
Measured: 12 months
Secondary outcomes (9)
radiographic evaluation with EOS
Use of the EOS system and 3D SterEOS software o carry out very precise measurements and 3D reconstructions by bone modeling which give access to new parameters
Measured: 12 months
Functional Interest
Stenosis self-questionnaire (Zurich Claudication Questionnaire)
Measured: 12 months
Sagittal parameters
PI (pelvic incidence) in degrees,
Measured: 12 months
Sagittal parameters
SS (sacral slope) in degrees
Measured: 12 months
Sagittal parameters
PT (pelvic tilt) in degrees
Measured: 12 months
Sagittal parameters
LL (lumbar lordosis) in degrees
Measured: 12 months
Sagittal parameters
TK in degrees
Measured: 12 months
Sagittal parameters
TPA (T1 Pelvic Angle) in degrees
Measured: 12 months
Sagittal parameters
C7 Barrey's ratio as a percentage
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2017
- Study startNov 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lumbar Stenosis, FamilialStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03065452
- Sponsor's protocol ID
- MADKOURI-BEAURAIN 2016
- Acronym
- CLE/EOS
- Status last verified
- Feb 2026
- First submitted
- 27 Jan 2017
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Madkouri R, Brauge D, Vidon-Buthion A, Fahed E, Mourier KL, Beaurain J, Grelat M. Improvement in Sagittal Balance After Decompression Surgery without Fusion in Patients with Degenerative Lumbar Stenosis: Clinical and Radiographic Results at 1 Year. World Neurosurg. 2018 Jun;114:e417-e424. doi: 10.1016/j.wneu.2018.03.002. Epub 2018 Mar 10.
PubMed 29530708
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sagittal Imbalance and Lumbar Stenosis Surgery: Decompression Without Implant
- ClinicalTrials.gov ID
- NCT03065452
- Acronym / sponsor ID
- CLE/EOS / MADKOURI-BEAURAIN 2016
- Conditions
- Lumbar Stenosis, Familial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 28 Feb 2017 (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.
Lumbar stenosis (LSS) is the most frequent degenerative lumbar disease and is the most frequent indication for spinal surgery. When non-invasive treatments fail, decompression surgery is the gold standard therapy for the majority of patients and generally improves symptoms.
However, few studies have investigated the improvement in posture (radiological parameters) after surgery. In lumbar stenosis, patients may present a forward leaning posture (to relieve pain), which is responsible for sagittal imbalance.
The aim of this prospective study was to evaluate the repercussions of decompression surgery on sagittal balance and to compare these with aux clinical results. investigators included patients operated on for isolated lumbar canal stenosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who underwent open decompression surgery | – | –Observational study on patients who underwent open decompression surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- consecutive patients who underwent open decompression surgery (laminotomy) were prospectively included in this study
Key inclusion criteria (3 listed)
- Symptoms and signs of neurogenic claudication and radiological signs of central lumbar stenosis;
- Patients undergoing open decompression surgery ≤ 3 levels,
- All patients with symptoms that did not respond to at least 3 months of non-invasive treatment.
Key exclusion criteria (5 listed)
- Patients were excluded from the study if they had one or several of the following clinical and/or radiological criteria:
- spondylolisthesis (disc slip > 5 mm),
- criteria showing instability (variation of > 10° in the angle formed by the vertebral endplates on dynamic images).
- scoliosis (Cobb angle > 20 °).
- Patients lost to follow-up were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Vertical sagittal axis
Time frame: 12 months
Evaluation of sagittal parameters
9 secondary outcomes
radiographic evaluation with EOS
Time frame: 12 months
Functional Interest
Time frame: 12 months
Sagittal parameters
Time frame: 12 months
Sagittal parameters
Time frame: 12 months
Sagittal parameters
Time frame: 12 months
Sagittal parameters
Time frame: 12 months
Sagittal parameters
Time frame: 12 months
Sagittal parameters
Time frame: 12 months
Sagittal parameters
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Results publication: PubMed 29530708Madkouri R, Brauge D, Vidon-Buthion A, Fahed E, Mourier KL, Beaurain J, Grelat M. Improvement in Sagittal Balance After Decompression Surgery without Fusion in Patients with Degenerative Lumbar Stenosis: Clinical and Radiographic Results at 1 Year. World Neurosurg. 2018 Jun;114:e417-e424. doi: 10.1016/j.wneu.2018.03.002. Epub 2018 Mar 10.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Stenosis, Familial, run by Centre Hospitalier Universitaire Dijon 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 5 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: finished, as of the sponsor's last update on 6 Feb 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vertical sagittal axis (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03065452, which also lists 1 linked publication.
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 6 Feb 2026; AzTrials last refreshed its copy on 6 Nov 2026.