Spinal Stenosis Lumbar Canal With Neurogenic Claudication (Diagnosis)
Conditions
Keywords
intraoperative procedures
Brief summary
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.
Interventions
PROCEDUREDecompression
Bilateral decompression
PROCEDUREPLIF
Traditional open surgery
PROCEDUREMIS TLIF
On the one side - Wiltse approach, on the other side - percutaneous
PROCEDUREScrew Fixation
Transpedicular Screw Fixation
Sponsors
Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
1. group - decompression, MIS TLIF + Screw Fixation 2. group - decompression, open fusion + Screw Fixation
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry Disability Index (ODI) | Day of hospital discharge (10-15 day after surgery) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VAS (back, leg) | Day of hospital discharge (10-15 day after surgery), 3, 6 and 12 months | 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 |
| Surgery duration | Day of surgery | Surgery duration, in minutes |
| Oswestry Disability Index (ODI) | 3, 6 and 12 months | 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 |
| MRI capacity spine canal | Day of hospital discharge (10-15 day after surgery) | Changes of spine canal capacity of spine segment, in sq. cm., as compared to baseline |
| Bone fusion | 12 months | Intervertebral bone fusion formation, in degree (I, II, III or IV degree according to Tan) |
| Blood loss | Day of surgery | Blood loss, in milliliter |
Countries
Russia
Outcome results
None listed