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OpenTrials
Completed

NCT Number: NCT03065452

Sagittal Imbalance and Lumbar Stenosis Surgery: Decompression Without Implant

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.

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Key information

Conditions

Lumbar Stenosis, Familial

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu de Dijon

Dijon, 21079, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Vertical sagittal axis

    Time frame: 12 months

    Evaluation of sagittal parameters

Secondary outcomes

  1. 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

  2. Functional Interest

    Time frame: 12 months

    Stenosis self-questionnaire (Zurich Claudication Questionnaire)

  3. Sagittal parameters

    Time frame: 12 months

    PI (pelvic incidence) in degrees,

  4. Sagittal parameters

    Time frame: 12 months

    SS (sacral slope) in degrees

  5. Sagittal parameters

    Time frame: 12 months

    PT (pelvic tilt) in degrees

  6. Sagittal parameters

    Time frame: 12 months

    LL (lumbar lordosis) in degrees

  7. Sagittal parameters

    Time frame: 12 months

    TK in degrees

  8. Sagittal parameters

    Time frame: 12 months

    TPA (T1 Pelvic Angle) in degrees

  9. Sagittal parameters

    Time frame: 12 months

    C7 Barrey's ratio as a percentage

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: CLE/EOS

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 28, 2017
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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