Sagittal Imbalance and Lumbar Stenosis Surgery: Decompression Without Implant

Lumbar Stenosis, Familial Clinical Trial

— CLE/EOS  

Official title:

Sagittal Imbalance and Lumbar Stenosis Surgery: Decompression Without Implant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03065452
• Other study ID #: MADKOURI-BEAURAIN 2016
• Status: Completed
• Phase: N/A
• First received: January 27, 2017
• Last updated: February 28, 2017
• Start date: November 2014
• Est. completion date: May 2016

Study information

• Verified date: November 2016
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Lumbar Stenosis, Familial

Locations

Country	Name	City	State
France	Chu de Dijon	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vertical sagittal axis	Evaluation of sagittal parameters	12 months
Secondary	radiographic evaluation with EOS	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	12 months
Secondary	Functional Interest	Stenosis self-questionnaire (Zurich Claudication Questionnaire)	12 months
Secondary	Sagittal parameters	PI (pelvic incidence) in degrees,	12 months
Secondary	Sagittal parameters	SS (sacral slope) in degrees	12 months
Secondary	Sagittal parameters	PT (pelvic tilt) in degrees	12 months
Secondary	Sagittal parameters	LL (lumbar lordosis) in degrees	12 months
Secondary	Sagittal parameters	TK in degrees	12 months
Secondary	Sagittal parameters	TPA (T1 Pelvic Angle) in degrees	12 months
Secondary	Sagittal parameters	C7 Barrey's ratio as a percentage	12 months