Minimally Invasive Decompression and Fusion Versus Open for Degenerative Lumbar Stenosis

Study Overview
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Brief Summary
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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.

Official Title
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An Open-Label Randomized Controlled Study of the Efficacy of Surgical Treatment in Patients With Single Level Lumbar Spinal Stenosis Using Minimally Invasive Decompression and Fusion and Traditional Open

Conditions
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Lumbar Spinal Stenosis, Intervertebral Disc Degeneration

Intervention / Treatment
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* Procedure: lumbar fusion


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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Minimally invasive TLIF<br>Patients will undergo a single level decompression and fusion using a minimally invasive technique. Followed posterior screw fixation is mandatory. | Procedure: lumbar fusion<br>* Transforaminal Lumbar Interbody Fusion will be performed using minimally invasive approach or traditional open technique.<br>|
| Other: Open TLIF<br>Patients will undergo a single level decompression and fusion using an open traditional technique. Followed posterior screw fixation is mandatory. | Procedure: lumbar fusion<br>* Transforaminal Lumbar Interbody Fusion will be performed using minimally invasive approach or traditional open technique.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | 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. | 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 | 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.'' | Through 2 years | 
| Change from baseline in Clinical Global Impression Of Change (CGIC) scale | To observe the change of CGIC through follow-up terms. The answers range from -2 Significantly worse compared to Baseline to +2 Significantly improved compared to Baseline. 7-points scale indicates the patient's condition assessed by physician. | Through 2 years | 
| Cost-effectiveness | Total cost of surgical procedure (implanted system, the salary for surgery team) and the cost of patient's staying at the clinic before discharge. | 14th day of hospital stay | 
| Fusion rate success | Interbody fusion rate on CT based on Tan grades | 12 months and 24 months post op | 
| Surgery duration | Surgery duration, min | Day of surgery | 
| Reoperations rate | Incidence of reoperations | Through 2 years | 
| Pelvic Incidence | To observe the sagittal balance parameter - Pelvic Incidence - by sagittal scans of spine by X-Ray, in degrees | Through 2 years | 
| Change from baseline in Pelvic Tilt | To observe the sagittal balance parameter - Pelvic Tilt - by sagittal scans of spine by X-Ray compared to baseline, in degrees | Through 2 years | 
| Change from baseline in Global Lordosis Angle | To observe the sagittal balance parameter - Global Lordosis Angle - by sagittal scans of spine by X-Ray compared to baseline, in degrees | Through 2 years | 
| Change from baseline in Segmental Lordosis | To observe the sagittal balance parameter - Segmental Lordosis (the angle of treated level) - by sagittal scans of spine by X-Ray compared to baseline, in degrees | Through 2 years | 
| Change from baseline in Sagittal Vertical Axis | To observe the sagittal balance parameter - Sagittal Vertical Axis - by sagittal scans of spine by X-Ray compared to baseline, in mm | Through 2 years | 
| Adverse Events | Document Adverse Events (incl. adverse events related to device) occurrence throughout the study | Through 2 years |