Minimally Invasive Decompression and Fusion Versus Open for Degenerative Lumbar Stenosis

N.N. Priorov National Medical Research Center of Traumatology and Orthopedics96 enrolled

Overview

The purpose of this study is to determine the effectiveness of minimally invasive decompression and fusion over the traditional open decompression and fusion in patients with single-level lumbar stenosis caused by degenerative spondylolisthesis. Postoperative follow-up will continue for 12 months. Сlinical, safety, radiological and cost-effectiveness endpoints will be evaluated.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Lumbar Spinal Stenosis Intervertebral Disc Degeneration

Interventions

lumbar fusionPROCEDURE

Transforaminal Lumbar Interbody Fusion will be performed using minimally invasive approach or traditional open technique.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 40-75 years; 2. Neurogenic claudication or bilateral radiculopathy caused by single level combination of degenerative stenosis and spondylolisthesis confirmed by MRI at one level L3-L4 or L4-L5 or L5-S1; 3. Symptoms persisting for at least three months prior to surgery; 4. Given written Informed Consent Form; 5. Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements; 6. Oswestry Disability Index score of at least 40/100 at baseline; Exclusion Criteria: 1. Bilateral foraminal stenosis requiring surgical decompression on both sides; 2. Degenerative spondylolisthesis Type 2B, 3 subtypes by Gille; 3. More than one symptomatic level requiring multi-level surgical decompression and/or fusion; 4. Any condition that cannot be treated with mini-invasive unilateral decompression and fusion; 5. Any contraindication or inability to undergo baseline and/or follow up MRI or X-ray as required per protocol; 6. Spondylolisthesis grade II or higher of any etiology; 7. Prior lumbar spinal fusion at any level; 8. Other non-degenerative spinal conditions that may have an impact on subject safety, wellbeing or the intent and conduct of the study; 9. History or presence of any other major neurological disease or condition that may interfere with the study assessments; 10. Severe arterial insufficiency of the legs or other peripheral vascular disease; 11. Previous enrollment in this study, current enrollment or plans to be enrolled in another study (in parallel to this study).

Locations (1)

Priorov National Medical Research Center of Traumatology and Orthopedics

Moscow, Russia

Outcomes

Primary Outcomes

Change from baseline in Oswestry Disability Index (ODI)

To observe the change of ODI as compared to baseline through follow-up terms. min - 0, - the best result, patient is active; max - 50 - the worst result, patient is not physically active

Time frame: 3 months

Secondary Outcomes

Change from baseline in Oswestry Disability Index (ODI)

To observe the change of ODI as compared to baseline through follow-up terms. min - 0, - the best result, patient is active; max - 50 - the worst result, patient is not physically active

Time frame: Through 2 years

Change from baseline in Numeric Pain Rating Score (NPRS)

To observe the change of NPRS as compared to baseline through follow-up terms (0 - no pain, 10 - unbearable pain)

Time frame: Through 2 years

Change from baseline in EuroQol Five-Dimensional descriptive system questionnaire (EQ-5D).

To observe the change of EQ-5D as compared to baseline through follow-up terms. It assesses 5 components related to aspects of life: mobility, self-care, activity in daily life, pain, anxiety or depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.

Time frame: Through 2 years

Change from baseline in Douleur Neuropathique 4 (DN4)

To observe the change of DN4 as compared to baseline through follow-up terms. The scale result ranges 0-10 points. The sum \> 4 points indicates the neuropathic component of pain

Time frame: Through 2 years

Change from baseline in The Health Transition Item from SF-36 (HTI Item)

To observe the change of HTI Item through follow-up terms. Patient's answers range from ''Much Better,'' ''Somewhat Better,'' ''About the Same,'' ''Somewhat Worse,'' to ''Much Worse.''

Data from ClinicalTrials.gov

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