- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03065452
Sagittal Imbalance and Lumbar Stenosis Surgery: Decompression Without Implant (CLE/EOS)
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 Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Dijon, France, 21079
- CHU de DIJON
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
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Patients who underwent open decompression surgery
Observational study on patients who underwent open decompression surgery
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vertical sagittal axis
Time Frame: 12 months
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Evaluation of sagittal parameters
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
radiographic evaluation with EOS
Time Frame: 12 months
|
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
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12 months
|
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Functional Interest
Time Frame: 12 months
|
Stenosis self-questionnaire (Zurich Claudication Questionnaire)
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12 months
|
|
Sagittal parameters
Time Frame: 12 months
|
PI (pelvic incidence) in degrees,
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12 months
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Sagittal parameters
Time Frame: 12 months
|
SS (sacral slope) in degrees
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12 months
|
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Sagittal parameters
Time Frame: 12 months
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PT (pelvic tilt) in degrees
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12 months
|
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Sagittal parameters
Time Frame: 12 months
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LL (lumbar lordosis) in degrees
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12 months
|
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Sagittal parameters
Time Frame: 12 months
|
TK in degrees
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12 months
|
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Sagittal parameters
Time Frame: 12 months
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TPA (T1 Pelvic Angle) in degrees
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12 months
|
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Sagittal parameters
Time Frame: 12 months
|
C7 Barrey's ratio as a percentage
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12 months
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MADKOURI-BEAURAIN 2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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