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Recruitment terminated, all follow-up visits were canceled due to quarantine
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minimally invasive fusion | Experimental | Bilateral decompression using unilateral approach, MIS TLIF + screw fixation percutaneous |
|
| Open Fusion | Active Comparator | Bilateral decompression, open fusion + screw fixation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decompression | Procedure | Bilateral decompression |
| |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aleksandr V Krutko, PhD, MD | Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan, Neurosurgery Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan | Novosibirsk | 630091 | Russia |
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| PLIF |
| Procedure |
Traditional open surgery |
|
| MIS TLIF | Procedure | On the one side - Wiltse approach, on the other side - percutaneous |
|
| Screw Fixation | Procedure | Transpedicular Screw Fixation |
|
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 |
| ID | Term |
|---|---|
| D004194 | Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003664 | Decompression |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D011312 | Pressure |
| D055595 | Mechanical Phenomena |
| D055585 | Physical Phenomena |
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