Cervical Degenerative Disc Disease, Cervical Stenosis, Posterior Spine Surgery
Conditions
Brief summary
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.
Interventions
PROCEDUREminimally invasive decompression via the posterior approach
All patients will undergo minimally invasive isolated decompression via the posterior approach to the cervical spine.
Sponsors
N.N. Priorov National Medical Research Center of Traumatology and Orthopedics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Over 18 years old; 2. Degenerative symptomatic cervical stenosis caused by posterior compression (hypertrophied ligament flavum and/or hypertrophied facet joints etc.) confirmed by MRI; 3. Symptoms persisting for at least 3 months prior to surgery; 4. Planned surgical decompression for one and more cervical level; 5. Given written Informed Consent; 6. Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements.
Exclusion criteria
1. The need for anterior cervical decompression; 2. Prior cervical fusion at any level; 3. Any contraindication or inability to undergo baseline and/or follow up MRI or X-ray as required per protocol; 4. Neck or non-radicular pain of unknown etiology; 5. History or presence of any other major neurological disease or condition that may interfere with the study assessments; 6. 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 in the cross-sectional area of the dural sac, mm2 | 3 months after surgery | To observe the change in the cross-sectional area of the dural sac by MRI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Japanese Orthopaedic Association scale | 3 months and 12 months postoperatively | 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) |
| Change from baseline in Neck Disability Index | 2 weeks (or at day of hospital discharge), 3 months, 12 and 12 months postoperatively | 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) |
| Change from baseline in The Health Transition Item from SF-36 | 2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively | 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.'') |
| Change in the cross-sectional area of the dural sac, mm2 | 12 months postoperatively | To observe the change in the cross-sectional area of the dural sac by MRI |
| Change from baseline in cervical balance parameters | 3 months and 12 months postoperatively | To observe the change of regional balance parameters - Cervical Lordosis - by sagittal scans of cervical spine by X-Ray compared to baseline, in degrees |
| Adverse Events | during study, an average of 1 year | Document Adverse Events (incl. adverse events related to device) occurrence throughout the study |
| Change from baseline in Numeric Pain Rating Scale | 2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively | To observe the change of Numeric Pain Rating Scale as compared to baseline through follow-up terms (0 - no pain, 10 - unbearable pain) |
Countries
Russia
Outcome results
None listed