Cervical Spinal Cord Injury, Cervical Spinal Stenosis, Individuation, Standardization
Conditions
Keywords
cervical spinal stenosis, open angle
Brief summary
To evaluate the safety and effectiveness of individualized, precise and standardized open-door posterior cervical surgery through a single-center, exploratory clinical study, so as to provide a more reliable basis for the treatment of cervical spinal stenosis.
Interventions
PROCEDURECenterpiece titanium plate
All indexes were collected from the patients with Centerpiece titanium plate for internal fixation.
Sponsors
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
28 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* The age of 28-85 years old; Through systematic clinical and imaging examination, patients diagnosed with C3-7 multilevel cervical spondylitis myelopathy or cervical spinal stenosis who need to undergo posterior cervical open-door surgery. * No contraindications in preoperative routine tests and examinations. * Informed consent of patients.
Exclusion criteria
* Cervical radiculopathy * Cervical kyphosis or instability * Cervical spondylosis caused by trauma, tumor, tuberculosis and metabolic diseases * Revision surgery or combined anterior-posterior surgery is required * Serious neurological diseases affect the postoperative effect evaluation * Mental illness cannot cooperate with follow-up * Contraindications for MRI examination * Patients themselves or their families do not agree to participate in the study * Other situations that are not suitable for study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| JOA score change | pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery | Japanese Orthopedic Association (JOA) score is used to assess the function of spinal cord which is in the form of questionnaires. Postoperative improvement rate = ((postoperative score - preoperative score)/ (17- preoperative score)) X100%. Improvement rate can also correspond to the commonly used efficacy criteria: cure when the improvement rate is 100%, effective when the improvement rate is greater than 60%, effective when 25-60%, and ineffective when less than 25%. |
| NDI score change | pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery | Neck Disability Index (NDI) score is used to assess the disorder of spinal cord which is in the form of questionnaires. Postoperative improvement rate = (total score)/ (numbers of program X5) X100%. Improvement rate can also correspond to the commonly used efficacy criteria: the improvement rate when 60%-80% means extremely severe dysfunction, when 40%-60% means severe dysfunction, when 20-40% means moderate dysfunction, and when less than 20% means mild dysfunction. |
| VAS score | pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery | A Visual Analogue Scale (VAS) is used to measure the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. Using a ruler, the score is determined by measuring the distance (mm) on the 10cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum spinal cord compression change | pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery | This index was measured by MRI, which was the ratio of the diameter of the cervical pulp at the most compressed segment to the mean diameter of the cervical pulp at the upper and lower segments without compression. |
| Compression ratio change | pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery | This index was measured by MRI, which means the minimum sagittal diameter of the cervical pulp in the most compressed segment divided by maximum transverse diameter. |
| Transverse area change | pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery | This index was measured by MRI, which means the cross-sectional area of the cervical pulp at the highest level of compression. |
Countries
China
Contacts
CONTACTWei Qi
Outcome results
None listed