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The purpose of this study is to determine the effectiveness of minimally invasive decompression and fusion over the traditional open decompression and fusion in patients with single-level lumbar stenosis caused by degenerative spondylolisthesis. Postoperative follow-up will continue for 12 months. Сlinical, safety, radiological and cost-effectiveness endpoints will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minimally invasive TLIF | Other | Patients will undergo a single level decompression and fusion using a minimally invasive technique. Followed posterior screw fixation is mandatory. |
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| Open TLIF | Other | Patients will undergo a single level decompression and fusion using an open traditional technique. Followed posterior screw fixation is mandatory. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lumbar fusion | Procedure | Transforaminal Lumbar Interbody Fusion will be performed using minimally invasive approach or traditional open technique. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Oswestry Disability Index (ODI) | To observe the change of ODI as compared to baseline through follow-up terms. min - 0, - the best result, patient is active; max - 50 - the worst result, patient is not physically active | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Oswestry Disability Index (ODI) | To observe the change of ODI as compared to baseline through follow-up terms. min - 0, - the best result, patient is active; max - 50 - the worst result, patient is not physically active | Through 2 years |
| Change from baseline in Numeric Pain Rating Score (NPRS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Priorov National Medical Research Center of Traumatology and Orthopedics | Moscow | 127299 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33674366 | Derived | Leonova ON, Cherepanov EA, Krutko AV. MIS-TLIF versus O-TLIF for single-level degenerative stenosis: study protocol for randomised controlled trial. BMJ Open. 2021 Mar 5;11(3):e041134. doi: 10.1136/bmjopen-2020-041134. |
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Data are available upon reasonable request. Please contact the corresponding author for detail.
During the study conducting and during 5 years after
The approval of institutional review board will be necessary
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| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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To observe the change of NPRS as compared to baseline through follow-up terms (0 - no pain, 10 - unbearable pain) |
| Through 2 years |
| Change from baseline in EuroQol Five-Dimensional descriptive system questionnaire (EQ-5D). | To observe the change of EQ-5D as compared to baseline through follow-up terms. It assesses 5 components related to aspects of life: mobility, self-care, activity in daily life, pain, anxiety or depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. | Through 2 years |
| Change from baseline in Douleur Neuropathique 4 (DN4) | To observe the change of DN4 as compared to baseline through follow-up terms. The scale result ranges 0-10 points. The sum > 4 points indicates the neuropathic component of pain | Through 2 years |
| Change from baseline in The Health Transition Item from SF-36 (HTI Item) | To observe the change of HTI Item through follow-up terms. Patient's answers range from ''Much Better,'' ''Somewhat Better,'' ''About the Same,'' ''Somewhat Worse,'' to ''Much Worse.'' | Through 2 years |
| Change from baseline in Clinical Global Impression Of Change (CGIC) scale | To observe the change of CGIC through follow-up terms. The answers range from "-2 Significantly worse compared to Baseline" to "+2 Significantly improved compared to Baseline". 7-points scale indicates the patient's condition assessed by physician. | Through 2 years |
| Cost-effectiveness | Total cost of surgical procedure (implanted system, the salary for surgery team) and the cost of patient's staying at the clinic before discharge. | 14th day of hospital stay |
| Fusion rate success | Interbody fusion rate on CT based on Tan grades | 12 months and 24 months post op |
| Surgery duration | Surgery duration, min | Day of surgery |
| Reoperations rate | Incidence of reoperations | Through 2 years |
| Pelvic Incidence | To observe the sagittal balance parameter - Pelvic Incidence - by sagittal scans of spine by X-Ray, in degrees | Through 2 years |
| Change from baseline in Pelvic Tilt | To observe the sagittal balance parameter - Pelvic Tilt - by sagittal scans of spine by X-Ray compared to baseline, in degrees | Through 2 years |
| Change from baseline in Global Lordosis Angle | To observe the sagittal balance parameter - Global Lordosis Angle - by sagittal scans of spine by X-Ray compared to baseline, in degrees | Through 2 years |
| Change from baseline in Segmental Lordosis | To observe the sagittal balance parameter - Segmental Lordosis (the angle of treated level) - by sagittal scans of spine by X-Ray compared to baseline, in degrees | Through 2 years |
| Change from baseline in Sagittal Vertical Axis | To observe the sagittal balance parameter - Sagittal Vertical Axis - by sagittal scans of spine by X-Ray compared to baseline, in mm | Through 2 years |
| Adverse Events | Document Adverse Events (incl. adverse events related to device) occurrence throughout the study | Through 2 years |