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| Name | Class |
|---|---|
| The First Affiliated Hospital of University of South China | OTHER |
| Guangzhou First People's Hospital | OTHER |
| The Seventh Affiliated Hospital of Sun Yat-sen University | OTHER |
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The goal of this clinical trial is to learn if cervical single-door laminoplasty via the intermuscular space approach can better prevent axial symptom while reaching equal neurological outcome than the conventional approach in adults patients with cervical spondylotic myelopathy. The main questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Via the intermuscular space | Experimental |
| |
| Control | Sham Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Expansive open-door laminoplasty via intermuscular space approach | Procedure | The cervical laminoplasty via intermuscular space approach will apply bilateral blunt dissection to create the operative space between capital semispinalis muscle and cervical semispinalis muscle |
| Measure | Description | Time Frame |
|---|---|---|
| modified Japanese Orthopedic Association score | Evaluate neurological function in 4 dimension with a total of 18 points: A. Upper limb motor dysfunction(5 points) B. Lower limb motor dysfunction(7 points) C. Sensory dysfunction(3 points) D. Sphincter dysfunction(3 points) | 2 years after operation |
| Measure | Description | Time Frame |
|---|---|---|
| modified Japanese Orthopedic Association Score | Evaluate neurological function in 4 dimension with a total of 18 points: A. Upper limb motor dysfunction(5 points) B. Lower limb motor dysfunction(7 points) C. Sensory dysfunction(3 points) D. Sphincter dysfunction(3 points) | Before surgery and 1week, 1month, 3months, 6months, 1year after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse reactions | Safety Metrics Incidence of adverse reactions= (amount of adverse reactions/amount of patients)*100% | 1 week, 1month, 3months, 6months, 1year and 2 years after surgery |
| Incidence of adverse events |
Inclusion Criteria:
Exclusion Criteria:
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| The Third Affiliated Hospital of Southern Medical University |
| OTHER_GOV |
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| cervical single-door laminoplasty via the conventional approach | Procedure | The cervical laminoplasty via the conventional approach will apply median dissection of the cervical spinous ligament and seperate muscles to expose the whole lamina of cervical vertebrae. |
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| Cervical Visual Analogue Scale Score | According to the severity of patient's neck pain, on a scale of 1-10, let patients themselves choose one score. 0 means no pain and 10 means extreme pain. | Before surgery; 1week, 1month, 3months, 6months, 1year and 2 years after surgery |
| Zeng's axial symptom scale | Based on the impact on work and life, and objective examination of neck paraspinal muscles and trapezius for spasms and tenderness, divided into 4 grades:
Those rated as excellent and good are considered to have no axial symptoms, while those rated as fair and poor are considered to have axial symptoms, and the incidence is calculated. | Before surgery; 1week, 1month, 3months, 6months, 1year and 2 years after surgery |
| Hosono axial symptom scale | According to patients' axial symptom and which treatment can alleviate it: Severe (regular need for analgesics or local injections), Moderate (regular need for physical therapy or compression), or Mild (no need for treatment). Severe and moderate are defined as having axial symptoms, while mild is defined as having no axial symptoms. | Before surgery; 1week, 1month, 3months, 6months, 1year and 2 years after surgery |
| Cervical 11-point Numerical Rating Scale | Based on neck symptoms, ask the patient to rate their condition on a scale from 0 to 10, where 0 indicates no symptoms and 10 indicates severe symptoms | Before surgery; 1week, 1month, 3months, 6months, 1year and 2 years after surgery |
Safety Metrics Incidence of adverse events= (amount of adverse events/amount of patients)*100%
| 1 week, 1month, 3months, 6months, 1year and 2 years after surgery |
| Incidence of severe adverse events | Safety Metrics Incidence of severe adverse events= (amount of severe adverse events/amount of patients)*100% | 1 week, 1month, 3months, 6months, 1year and 2 years after surgery |
| Mortality | Safety Metrics Mortality= (amount of death/amount of patients)*100% | 1 week, 1month, 3months, 6months, 1year and 2 years after surgery |