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

Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan132 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

132

Conditions

Spinal Stenosis Lumbar Canal With Neurogenic Claudication (Diagnosis)

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: Day of hospital discharge (10-15 day after surgery)

Secondary Outcomes

Oswestry Disability Index (ODI)

Time frame: 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

Time frame: Day of hospital discharge (10-15 day after surgery), 3, 6 and 12 months

Surgery duration

Surgery duration, in minutes

Time frame: Day of surgery

Blood loss

Blood loss, in milliliter

Time frame: Day of surgery

MRI capacity spine canal

Changes of spine canal capacity of spine segment, in sq. cm., as compared to baseline

Time frame: 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)

Time frame: 12 months