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Clinical Trials/NCT03065452
NCT03065452
Completed
Not Applicable

Sagittal Imbalance and Lumbar Stenosis Surgery: Decompression Without Implant

Centre Hospitalier Universitaire Dijon1 site in 1 country72 target enrollmentNovember 1, 2014

Overview

Phase
Not Applicable
Intervention
Patients who underwent open decompression surgery
Conditions
Lumbar Stenosis, Familial
Sponsor
Centre Hospitalier Universitaire Dijon
Enrollment
72
Locations
1
Primary Endpoint
Vertical sagittal axis
Status
Completed
Last Updated
2 months ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2014
End Date
May 1, 2016
Last Updated
2 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Arms & Interventions

Patients who underwent open decompression surgery

Observational study on patients who underwent open decompression surgery

Outcomes

Primary Outcomes

Vertical sagittal axis

Time Frame: 12 months

Evaluation of sagittal parameters

Secondary Outcomes

  • radiographic evaluation with EOS(12 months)
  • Functional Interest(12 months)
  • Sagittal parameters(12 months)

Study Sites (1)

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