Sagittal Imbalance and Lumbar Stenosis Surgery: Decompression Without Implant

Completed

• Conditions: Lumbar Stenosis, Familial

• Registration Number: NCT03065452
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-11
• Study First Submitted: 2017-01-27
• Study First Submitted QC: 2017-02-22
• Study First Posted: 2017-02-28
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

1. Symptoms and signs of neurogenic claudication and radiological signs of central lumbar stenosis;
2. Patients undergoing open decompression surgery ≤ 3 levels,
3. 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:

1. spondylolisthesis (disc slip > 5 mm),
2. criteria showing instability (variation of > 10° in the angle formed by the vertebral endplates on dynamic images).
3. scoliosis (Cobb angle > 20 °).
4. Patients lost to follow-up were excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vertical sagittal axis	12 months	Evaluation of sagittal parameters

Secondary Outcome Measures

Name	Time	Method
radiographic evaluation with EOS	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
Functional Interest	12 months	Stenosis self-questionnaire (Zurich Claudication Questionnaire)
Sagittal parameters	12 months	C7 Barrey's ratio as a percentage

Trial Locations

Locations (1)

Chu de Dijon; 🇫🇷 Dijon, France