About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >18
Patients with cervical spondylotic myelopathy meeting surgery indications.
Sign informed consent
Disqualifiers
Poor general condition, can not tolerate surgery
Patients with long course of disease, degenerative spinal cord, atrophy of limb muscles, and severe joint dysfunction
The cervical spine has obvious segmental instability, especially in the case of injury or lesion of the anterior structure, which has not been healed
History of cervical spine surgery
Trial design
Parallel
Treatments tested in this trial
Expansive open-door laminoplasty via intermuscular space approach
Procedure/SurgeryThe cervical laminoplasty via intermuscular space approach will apply bilateral blunt dissection to create the operative space between capital semispinalis muscle and cervical semispinalis muscle
cervical single-door laminoplasty via the conventional approach
Procedure/SurgeryThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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)
Secondary outcomes
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)
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.
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: * "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.
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.
Other outcomes
Incidence of adverse reactions
Safety Metrics Incidence of adverse reactions= (amount of adverse reactions/amount of patients)\*100%
Incidence of adverse events
Safety Metrics Incidence of adverse events= (amount of adverse events/amount of patients)\*100%
Incidence of severe adverse events
Safety Metrics Incidence of severe adverse events= (amount of severe adverse events/amount of patients)\*100%
Mortality
Safety Metrics Mortality= (amount of death/amount of patients)\*100%
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead sponsor
The First Affiliated Hospital of University of South China
Collaborator
Guangzhou First People's Hospital
Collaborator
The Seventh Affiliated Hospital of Sun Yat-sen University
Collaborator
The Third Affiliated Hospital of Southern Medical University
Collaborator
This trial is not recruiting at the moment. You can still explore other options: