Study of Individualized, Precise and Standardized Cervical Open-door Surgery for Cervical Spinal Stenosis

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Controlled Clinical Study of Individualized, Precise and Standardized Posterior Cervical Open-door Surgery for Cervical Spinal Stenosis

Conditions
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Cervical Spinal Stenosis, Cervical Spinal Cord Injury, Individuation, Standardization

Intervention / Treatment
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* Procedure: Centerpiece titanium plate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 28 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Centerpiece titanium plate<br>All surgical operations were performed by the same group of senior spine surgeons. The range of open door decompression involved C3   C7. For convenient operation and more accurate statistics, the right side of the door axis and the left side of the door seam were selected for all operations. Centerpiece titanium plates were used for intraoperative fixation. | Procedure: Centerpiece titanium plate<br>* All indexes were collected from the patients with Centerpiece titanium plate for internal fixation.<br>|
| Experimental: 3D printed arch titanium plate<br>Before surgery, according to the imaging results, according to the effective imaging indicators screened in the early stage and the calculated door opening Angle formula, the door opening Angle of the patient's posterior cervical vertebra and the size of the fitted arch titanium plate were designed by mimics 10.0 software, and the titanium plate was printed using 3D printing technology. During the operation, the developed laminae opener was used to accurately control the door opening Angle and appropriate size titanium plate was installed for internal fixation. The standardized laminae door opening guide was used to complete the preparation of the door shaft side and door opening side of the lamina | Procedure: Centerpiece titanium plate<br>* All indexes were collected from the patients with Centerpiece titanium plate for internal fixation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| JOA score change | 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%. | pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery | 
| NDI score change | 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. | pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery | 
| VAS score | 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. | pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum spinal cord compression change | 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. | pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery | 
| Compression ratio change | 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. | pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery | 
| Transverse area change | This index was measured by MRI, which means the cross-sectional area of the cervical pulp at the highest level of compression. | pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical spinal stenosis, open angle