Correlation Between Parameters and Prognosis of Cervical Single Open-door Surgery

Study Overview
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Brief Summary
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The aim of study was evaluated the relationship between the relevant evaluation indexes of cervical spine open-door surgery, prognosis and complication rate, and provided theoretical basis for personalized surgical program through multi-center retrospective clinical study

Official Title
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Correlation Between Parameters and Prognosis of Cervical Single Open-door Surgery: a Multicenter Retrospective Clinical Study

Conditions
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Cervical Spinal Stenosis

Intervention / Treatment
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* Procedure: cervical single open-door surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptoms and signs of the patients were typical. MRI showed single or multiple central herniation of C3-C7 intervertebral discs or spinal stenosis at corresponding levels, which confirmed cervical myeloid cervical spondylosis or cervical spinal stenosis. Conservative treatment for more than 3 months before surgery was ineffective. The patients underwent cervical single open-door surgery. Informed consent was obtained from the patient and his family, informed consent was signed, and a complete follow-up was completed after surgery Exclusion Criteria: Cervical spondylotic radiculopathy. Cervical kyphosis or instability. Cervical spondylosis caused by trauma, tumor, tuberculosis and metabolic diseases. Revision surgery or combined anterior-posterior surgery is required. The patients had severe neurological diseases affecting the evaluation of postoperative results. Psychopath. MRI or CT for contraindications.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 86 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Preoperative<br> | |
| Experimental: postoperative (3 months)<br> | Procedure: cervical single open-door surgery<br>* The patients were operated by the cervical single open-door surgery, which were used with the Centerpiece titanium plate to internal fixation.<br>|
| Experimental: postoperative (6 months)<br> | Procedure: cervical single open-door surgery<br>* The patients were operated by the cervical single open-door surgery, which were used with the Centerpiece titanium plate to internal fixation.<br>|
| Experimental: postoperative (1 year)<br> | Procedure: cervical single open-door surgery<br>* The patients were operated by the cervical single open-door surgery, which were used with the Centerpiece titanium plate to internal fixation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lamina open angle | The Angle of opening of the cervical unilateral lamina while cervical single open-door surgery | 3 months after surgery | 
| 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, 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 programme 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, 1 year after surgery | 
| VAS score change | 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 | 

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, 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, 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, 1 year after surgery | 
| Sagittal Canal Diameter change | This index was measured by CT, which was sagittal diameter of the spinal canal at the most compressed level. | pre-operation,3 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 single open-door surgery, Cervical Spinal Stenosis, Open angle