Intervertebral Disc Degeneration, Lumbar Spinal Stenosis
Conditions
Brief summary
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.
Interventions
PROCEDURElumbar fusion
Transforaminal Lumbar Interbody Fusion will be performed using minimally invasive approach or traditional open technique.
Sponsors
N.N. Priorov National Medical Research Center of Traumatology and Orthopedics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age 40-75 years; 2. Neurogenic claudication or bilateral radiculopathy caused by single level combination of degenerative stenosis and spondylolisthesis confirmed by MRI at one level L3-L4 or L4-L5 or L5-S1; 3. Symptoms persisting for at least three months prior to surgery; 4. Given written Informed Consent Form; 5. Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements; 6. Oswestry Disability Index score of at least 40/100 at baseline;
Exclusion criteria
1. Bilateral foraminal stenosis requiring surgical decompression on both sides; 2. Degenerative spondylolisthesis Type 2B, 3 subtypes by Gille; 3. More than one symptomatic level requiring multi-level surgical decompression and/or fusion; 4. Any condition that cannot be treated with mini-invasive unilateral decompression and fusion; 5. Any contraindication or inability to undergo baseline and/or follow up MRI or X-ray as required per protocol; 6. Spondylolisthesis grade II or higher of any etiology; 7. Prior lumbar spinal fusion at any level; 8. Other non-degenerative spinal conditions that may have an impact on subject safety, wellbeing or the intent and conduct of the study; 9. History or presence of any other major neurological disease or condition that may interfere with the study assessments; 10. Severe arterial insufficiency of the legs or other peripheral vascular disease; 11. Previous enrollment in this study, current enrollment or plans to be enrolled in another study (in parallel to this study).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Oswestry Disability Index (ODI) | 3 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Oswestry Disability Index (ODI) | Through 2 years | 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 |
| Change from baseline in Numeric Pain Rating Score (NPRS) | Through 2 years | To observe the change of NPRS as compared to baseline through follow-up terms (0 - no pain, 10 - unbearable pain) |
| Change from baseline in EuroQol Five-Dimensional descriptive system questionnaire (EQ-5D). | Through 2 years | 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. |
| Change from baseline in Douleur Neuropathique 4 (DN4) | Through 2 years | 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 |
| Change from baseline in The Health Transition Item from SF-36 (HTI Item) | Through 2 years | 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.'' |
| Change from baseline in Clinical Global Impression Of Change (CGIC) scale | Through 2 years | 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. |
| Cost-effectiveness | 14th day of hospital stay | Total cost of surgical procedure (implanted system, the salary for surgery team) and the cost of patient's staying at the clinic before discharge. |
| Fusion rate success | 12 months and 24 months post op | Interbody fusion rate on CT based on Tan grades |
| Surgery duration | Day of surgery | Surgery duration, min |
| Reoperations rate | Through 2 years | Incidence of reoperations |
| Pelvic Incidence | Through 2 years | To observe the sagittal balance parameter - Pelvic Incidence - by sagittal scans of spine by X-Ray, in degrees |
| Change from baseline in Pelvic Tilt | Through 2 years | To observe the sagittal balance parameter - Pelvic Tilt - by sagittal scans of spine by X-Ray compared to baseline, in degrees |
| Change from baseline in Global Lordosis Angle | Through 2 years | To observe the sagittal balance parameter - Global Lordosis Angle - by sagittal scans of spine by X-Ray compared to baseline, in degrees |
| Change from baseline in Segmental Lordosis | Through 2 years | 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 |
| Change from baseline in Sagittal Vertical Axis | Through 2 years | To observe the sagittal balance parameter - Sagittal Vertical Axis - by sagittal scans of spine by X-Ray compared to baseline, in mm |
| Adverse Events | Through 2 years | Document Adverse Events (incl. adverse events related to device) occurrence throughout the study |
Countries
Russia
Outcome results
None listed