Comparison of Open and Minimally Invasive Surgical Techniques in the Treatment of Degenerative One-level Stenosis of Lumbar Spine

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the clinical and radiological results of surgical treatment of one-level central stenosis of the lumbar spine using traditional open approach (PLIF) and a minimally invasive procedure (MIS TLIF). According to the hypothesis, we assume that unilateral approach of MIS TLIF allows for adequate bilateral decompression of one-level central stenosis of the lumbar spine. Using MIS TLIF it is possible to perform reliable fixation of a spine segment and the formation of a complete intervertebral bone fusion. The long-term clinical results of surgical treatment with minimally invasive technologies (MIS TLIF) and traditional open approach (PLIF) suspected to be comparable.

Official Title
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Prospective Comparative Study of Open and Minimally Invasive Surgical Techniques in the Treatment of Degenerative One-level Stenosis of Lumbar Spine

Conditions
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Spinal Stenosis Lumbar Canal With Neurogenic Claudication (Diagnosis)

Intervention / Treatment
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* Procedure: Decompression
* Procedure: PLIF
* Procedure: MIS TLIF
* Procedure: Screw Fixation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: syndrome of mono- or polyradicular compression of the nerve roots with / without a reflex pain syndromes, caused by stenosis of one lumbar spine segment; intermittent claudication caused by stenosis of one lumbar spine segment; one-level spine stenosis in combination with local segment instability or degenerative spondylolisthesis at the same spine segment, requiring fusion in only one lumbar segment Exclusion Criteria: bilateral foraminal lumbar spine stenosis; lumbar spine stenosis more than one-level; spondylolisthesis II degree and more; sagittal imbalance; fusion the same lumbar spine segment after surgery previously; other diseases of the spine, including trauma, tumor and inflammatory diseases of the lumbar spine, etc.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: group - decompression, MIS TLIF + Screw Fixation group - decompression, open fusion + Screw Fixation
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Minimally invasive fusion<br>Bilateral decompression using unilateral approach, MIS TLIF + screw fixation percutaneous | Procedure: Decompression<br>* Bilateral decompression<br>Procedure: MIS TLIF<br>* On the one side - Wiltse approach, on the other side - percutaneous<br>Procedure: Screw Fixation<br>* Transpedicular Screw Fixation<br>|
| Active Comparator: Open Fusion<br>Bilateral decompression, open fusion + screw fixation | Procedure: Decompression<br>* Bilateral decompression<br>Procedure: PLIF<br>* Traditional open surgery<br>Procedure: Screw Fixation<br>* Transpedicular Screw Fixation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index (ODI) | Oswestry Disability Index - patient-reported physical and household activity. Minimum - 0 (the worst result, patient is not physically active). Maximum - 50 (the best result). Improvement of ODI post-operatively as compared to baseline | Day of hospital discharge (10-15 day after surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index (ODI) | Oswestry Disability Index - patient-reported physical and household activity. Minimum - 0 (the worst result, patient is not physically active). Maximum - 50 (the best result). Improvement of ODI as compared to baseline | 3, 6 and 12 months | 
| VAS (back, leg) | Visual Analogue Scale (VAS) - patient-reported pain intensity (0 - no pain, 10 - unbearable pain). Improvement of VAS back- and leg pain intensity as compared to baseline | Day of hospital discharge (10-15 day after surgery), 3, 6 and 12 months | 
| Surgery duration | Surgery duration, in minutes | Day of surgery | 
| Blood loss | Blood loss, in milliliter | Day of surgery | 
| MRI capacity spine canal | Changes of spine canal capacity of spine segment, in sq. cm., as compared to baseline | Day of hospital discharge (10-15 day after surgery) | 
| Bone fusion | Intervertebral bone fusion formation, in degree (I, II, III or IV degree according to Tan) | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intraoperative procedures