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Degenerative stenosis of the cervical spinal canal may be caused by the compression of the posterior part of the dural sac and spinal cord by the hypertrophied ligamentum flavum and facet joints, by the compression of the anterior part of the dural sac and spinal cord by the posterior longitudinal ligament, vertebral osteophytes and protrusion/ herniation.
The choice of surgical treatment in such cases is challenging. Posterior decompression and fixation is often proposed, but it is associated with a traumatic posterior approach, a large wound, and blood loss, a high risk of surgery site infections, and also instability of the metal fixation is possible. Also important is the increase in the surgical procedure cost due to the use of metal implants. An excellent alternative to standard posterior decompression and fixation is a method with isolated decompression of the cervical canal via posterior approach, which does not require any metal fixation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort | Other | All patients will undergo minimally invasive isolated decompression via the posterior approach to the cervical spine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| minimally invasive decompression via the posterior approach | Procedure | All patients will undergo minimally invasive isolated decompression via the posterior approach to the cervical spine. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the cross-sectional area of the dural sac, mm2 | To observe the change in the cross-sectional area of the dural sac by MRI | 3 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Japanese Orthopaedic Association scale | To observe the change from baseline in Japanese Orthopaedic Association scale at 3 months after surgery (0 points - the severest myelopathy, 17 points - no myelopathy) | 3 months and 12 months postoperatively |
| Change from baseline in Neck Disability Index |
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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 |
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To observe the change of Oswestry Disability Index 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) |
| 2 weeks (or at day of hospital discharge), 3 months, 12 and 12 months postoperatively |
| Change from baseline in The Health Transition Item from SF-36 | To observe the change of The Health Transition Item as compared to baseline through follow-up terms (Patient's answers range from ''Much Better,'' ''Somewhat Better,'' ''About the Same,'' ''Somewhat Worse,'' to ''Much Worse.'') | 2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively |
| Change in the cross-sectional area of the dural sac, mm2 | To observe the change in the cross-sectional area of the dural sac by MRI | 12 months postoperatively |
| Change from baseline in cervical balance parameters | To observe the change of regional balance parameters - Cervical Lordosis - by sagittal scans of cervical spine by X-Ray compared to baseline, in degrees | 3 months and 12 months postoperatively |
| Change from baseline in cervical balance parameters | To observe the change of regional balance parameters - Segmental Lordosis - by sagittal scans of cervical spine by X-Ray compared to baseline, in degrees | 3 months and 12 months postoperatively |
| Change from baseline in cervical balance parameters | To observe the change of regional balance parameters - C2-C7 Sagittal Vertical Axis - - by sagittal scans of cervical spine by X-Ray compared to baseline, in degrees | 3 months and 12 months postoperatively |
| Adverse Events | Document Adverse Events (incl. adverse events related to device) occurrence throughout the study | during study, an average of 1 year |
| Change from baseline in Numeric Pain Rating Scale | To observe the change of Numeric Pain Rating Scale as compared to baseline through follow-up terms (0 - no pain, 10 - unbearable pain) | 2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively |