The Necessity of Fusion Following Decompression Surgery in Patients With Single-level Lumbar Stenosis
Study Details
Study Description
Brief Summary
Long-term clinical results of two methods of surgical treatment (spinal decompression with or without fusion) in patients with single-level lumbar stenosis will be compared. A clear framework for surgical treatment methods and standardized postoperative rehabilitation treatment will be set to obtain the maximum homogeneity of the patient groups.
This trial should provide the first level of evidence for the need for spinal fusion in patients with single-level lumbar stenosis, subject to the high homogeneous comparison groups. Additional results will allow comparing the economic aspects of different surgical treatments for 2 years after surgery.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
The main purpose of the trial is to compare the long-term clinical results of two methods of surgical treatment (spinal decompression with or without fusion) in patients with single-level lumbar stenosis. In total, surgeons from 3 hospitals providing surgical care to patients with degenerative diseases of the spine will be involved in the study. Two methods of surgical treatment for lumbar stenosis will be compared. In the decompression group, the spinous process, interspinous and supraspinous ligaments, part of the facet joints, and the corresponding part of the vertebral arch will be preserved intact. In the fusion group, decompression will be accompanied by trans-foraminal interbody fusion with a cage and pedicle screw fixation. Patients who meet the inclusion criteria and signed consent to take part in the study will be randomly divided into 2 groups in a 1:1 ratio, depending on the method of surgical intervention. Block randomization will be used, stratified by the stenosis. The final sample size will be 86 patients (43 in each group). Follow-up examinations will be carried out in 3, 6, 12, and 24 months.
This trial should provide the first level of evidence for the need for spinal fusion in patients with single-level lumbar stenosis, subject to the high homogeneous comparison groups. Additional results will allow comparing the economic aspects of different surgical treatments for 2 years after surgery.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: decompression group minimally invasive decompression without fusion |
Procedure: decompression
laminotomy of the corresponding adjacent vertebrae, partial flavectomy, and medial facetectomy will be performed first on one side. Further, depending on the personal preferences of the surgeon, 2 options for the operation are possible: 1) a similar decompression procedure on the other side; 2) a contralateral decompression. Regardless of the option chosen, in all patients of this group, the spinous process, interspinous and supraspinous ligaments, part of the facet joints, and the corresponding part of the vertebral arch should be preserved intact.
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| Other: fusion group minimally invasive decompression with trans-foraminal interbody fusion |
Procedure: fusion
First, decompression is performed according to one of the above methods. Next, trans-foraminal interbody fusion with a cage (TLIF) and fixation with pedicle screws are performed.
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Outcome Measures
Primary Outcome Measures
- Oswestry Disability Index [24 months]
The questionnaire includes 10 sections containing 6 statements each. Depending on the answer, a score is assigned (from 0 to 5). The maximum number of points is 50. After that, the points are converted into percentages (from 0 to 100%).
Secondary Outcome Measures
- SF-36 v.1 scale (standard form) [24 months]
The questionnaire contains 36 questions, grouped into 8 scales that assess physical functioning, role-playing, bodily pain, general health, vitality, social functioning, emotional state, and mental health. For each of them, the maximum score is 100 points.
- EQ-5D-5L [24 months]
The questionnaire contains 5 sections (mobility, self-care, usual activities, pain, anxiety) of three statements and the EQ-VAS visual analog pain scale. The results can be converted into a single numerical value (index) adjusted for the patient's region of residence
- Won-Korff Chronic Pain Syndrome Assessment Scale [24 months]
allows evaluating the severity of pain and its impact on life in points. Grade 0 corresponds to the absence of pain, and grade IV to the maximum limitation of life because of severe pain.
- Pain Catastrophizing Scale [24 months]
makes it possible to assess completely the psychological aspects of pain perception, in particular the exaggerated negative perception of painful stimuli. The questionnaire contains 13 questions, each of which is evaluated in points (0 points, no symptom, 4, the patient experiences these feelings all the time).
- Chronic Pain Coping Inventory [24 months]
allow one of eight scales to classify a patient's preferred strategy for coping with chronic pain.
- scale of the American Society of Anesthesiologists ASA [baseline]
This classification distinguishes 5 classes of physical status depending on the presence of concomitant diseases (Class I, healthy patient, Class V, dying).
- The cost of the treatment [24 months]
The cost of hospitalization of the patient, including the performance of surgical intervention, as well as the period of the patient's incapacity for work because of spinal disease, will also be calculated. Also, within 2 years after the intervention, the cost of subsequent treatment in rehabilitation centers and other hospitals for complications of the operation or other manifestations of degenerative-dystrophic changes in the lumbar spine will be considered.
- quality of fusion [24 months]
according to CT data, the quality of fusion using the Tan criteria will be graded into one of four grades of fusion-grade I (complete fusion) to grade IV (bipolar pseudarthrosis)
- pelvic tilt (PT) [24 months]
a parameter defined as the angle created by a line running from the sacral endplate midpoint to the center of the bifemoral heads and the vertical axis. Will be evaluated on X-ray.
- pelvic incidence (PI) [24 months]
the angle between the line perpendicular to the sacral endplate at its midpoint and a line connecting this point to the axis of the femoral head. Will be evaluated on X-ray.
- sacral slope (SS) [24 months]
the angle between the tangent line to the superior endplate of S1 and the horizontal plane. Will be evaluated on X-ray.
- al axis displacement (SVA) [24 months]
a horizontal distance between a plumb line dropped from the center of the C7 body and the posterior-superior corner of the S1 body. Will be evaluated on X-ray.
Eligibility Criteria
Criteria
Inclusion Criteria:
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age of patients from 45 to 75 years;
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stenosis C or D according to Shizas et al. according to MRI at the level of L2-L3, L3-L4, L4-L5 or L5-S1;
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clinical manifestations of lumbar stenosis (neurogenic claudication syndrome and/or radiculopathy);
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lack of effect from conservative therapy within 3 months;
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Informed consent to take part in the study.
Exclusion Criteria:
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spondylolisthesis more than 3 mm;
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spinal instability according to functional radiography;
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sagittal imbalance (type 4 according to C. Barrey);
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bone density of the vertebrae at the level of the operation is less than 100 HU;
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clinically significant spinal stenosis at 2 or more levels;
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previously performed surgeries on the spine;
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risk of anesthesia 4 or 5 according to ASA;
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inability to take part in control examinations within 2 years after the operation;
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participation in other clinical trials related to surgical or conservative treatment of diseases of the spine.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Federal State Budgetary Institution "Federal Center for Brain and Neurotechnologies" FMBA | Moscow | Russian Federation | 105203 | |
| 2 | Pirogov National Medical and Surgical Center | Moscow | Russian Federation | 105203 | |
| 3 | Sklifosovsky Research Institute for Emergency Medicine | Moscow | Russian Federation | 107045 |
Sponsors and Collaborators
- Sklifosovsky Institute of Emergency Care
- Pirogov National Medical Surgical Center
- Federal State Budgetary Institution "Federal Center for Brain and Neurotechnologies" FMBA
- Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine
- Moscow Center for Innovative Technologies in Healthcare
Investigators
- Study Chair: Andrey Grin, MD, PhD, Sklifosovsky Research Institute for Emergency Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 03\2022