Spinal Stenosis Lumbar Canal With Neurogenic Claudication (Diagnosis) Clinical Trial
Official title:
Prospective Comparative Study of Open and Minimally Invasive Surgical Techniques in the Treatment of Degenerative One-level Stenosis of Lumbar Spine
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.
| Status | Terminated |
| Enrollment | 132 |
| Est. completion date | February 15, 2020 |
| Est. primary completion date | February 15, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Russian Federation | Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan | Novosibirsk |
| Lead Sponsor | Collaborator |
|---|---|
| Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan |
Russian Federation,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | Surgery duration | Surgery duration, in minutes | Day of surgery | |
| Secondary | Blood loss | Blood loss, in milliliter | Day of surgery | |
| Secondary | 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) | |
| Secondary | Bone fusion | Intervertebral bone fusion formation, in degree (I, II, III or IV degree according to Tan) | 12 months |