Sagittal Imbalance and Lumbar Stenosis Surgery: Decompression Without Implant

NCT03065452 | Completed

• 1 other identifier: MADKOURI-BEAURAIN 2016
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Stenosis, Familial

Outcome Measures

Primary Outcomes (1)

• Vertical sagittal axis

  Evaluation of sagittal parameters

  12 months

Secondary Outcomes (9)

• radiographic evaluation with EOS

  12 months

• Functional Interest

  12 months

• Sagittal parameters

  12 months

• Sagittal parameters

  12 months

• Sagittal parameters

  12 months

Study Arms (1)

Patients who underwent open decompression surgery

Observational study on patients who underwent open decompression surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

consecutive patients who underwent open decompression surgery (laminotomy) were prospectively included in this study

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu de Dijon

Dijon, 21079, France

Location

Related Publications (1)

• 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.

  PMID: 29530708 RESULT

MeSH Terms

Conditions

Lumbar Stenosis, Familial

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2017
• First Posted: February 28, 2017
• Study Start: November 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)