Cervical Spondylotic Myelopathy
Conditions
Brief summary
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: * Can cervical single-door laminoplasty via the intermuscular space approach better prevent axial symptom than the conventional approach? * Can cervical single-door laminoplasty via the intermuscular space approach reach the neurological outcome not second to the conventional approach? If there is a comparison group: Researchers will compare the intermuscular space approach and the conventional approach of cervical single-door laminoplasty to see if the intermuscular space approach better prevent axial symptom. Participants will: * Received cervical single-door laminoplasty via the intermuscular space approach or the conventional approach once meet the indication. * Visit the clinic 1 month, 3 months, 6 months, 1 year and 2 years after the surgery. * Keep a diary of their symptoms and other unexpected conditions.
Interventions
PROCEDUREExpansive open-door laminoplasty via intermuscular space approach
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
PROCEDUREcervical single-door laminoplasty via the conventional approach
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.
Sponsors
The First Affiliated Hospital of University of South China
Guangzhou First People's Hospital
The Seventh Affiliated Hospital of Sun Yat-sen University
The Third Affiliated Hospital of Southern Medical University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \>18 2. Patients with cervical spondylotic myelopathy meeting surgery indications. 3. Sign informed consent
Exclusion criteria
1. Poor general condition, can not tolerate surgery 2. Patients with long course of disease, degenerative spinal cord, atrophy of limb muscles, and severe joint dysfunction 3. The cervical spine has obvious segmental instability, especially in the case of injury or lesion of the anterior structure, which has not been healed 4. History of cervical spine surgery 5. Combined with obvious cervical kyphosis 6. Combined with cervical fracture, dislocation, etc 7. Combined with cervical spinal infection, arthritis and other pathological changes 8. Combined with tumors of cervical spine or spinal cord. 9. Mental retardation or other causes of limited behavioral ability
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| modified Japanese Orthopedic Association score | 2 years after operation | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| modified Japanese Orthopedic Association Score | Before surgery and 1week, 1month, 3months, 6months, 1year after surgery | 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) |
| Hosono axial symptom scale | Before surgery; 1week, 1month, 3months, 6months, 1year and 2 years after surgery | 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. |
| Cervical Visual Analogue Scale Score | Before surgery; 1week, 1month, 3months, 6months, 1year and 2 years after surgery | 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. |
| Zeng's axial symptom scale | Before surgery; 1week, 1month, 3months, 6months, 1year and 2 years after surgery | 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: * Excellent: No abnormal sensations in the neck, no tenderness or muscle spasms; * Good: Mild symptoms after fatigue or cold exposure, but quick recovery, no significant impact on daily work and life, no tenderness or mild spasms in neck muscles, no need for painkillers; * Fair: Symptoms often appear \<100 days/year, daily work and life are somewhat affected, mild tenderness or spasms in neck muscles, need for painkillers with good effect; * Poor: Symptoms frequent (\>100 days/year), significantly affecting daily work and life, obvious tenderness or spasms in neck muscles, need for painkillers with poor effect. 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. |
| Cervical 11-point Numerical Rating Scale | Before surgery; 1week, 1month, 3months, 6months, 1year and 2 years after surgery | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of severe adverse events | 1 week, 1month, 3months, 6months, 1year and 2 years after surgery | Safety Metrics Incidence of severe adverse events= (amount of severe adverse events/amount of patients)\*100% |
| Mortality | 1 week, 1month, 3months, 6months, 1year and 2 years after surgery | Safety Metrics Mortality= (amount of death/amount of patients)\*100% |
| Incidence of adverse events | 1 week, 1month, 3months, 6months, 1year and 2 years after surgery | Safety Metrics Incidence of adverse events= (amount of adverse events/amount of patients)\*100% |
| Incidence of adverse reactions | 1 week, 1month, 3months, 6months, 1year and 2 years after surgery | Safety Metrics Incidence of adverse reactions= (amount of adverse reactions/amount of patients)\*100% |
Outcome results
None listed