Efficacy of Two Approaches in Cervical Single-door Laminoplasty for Spinal Canal Enlargement

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Expansive open-door laminoplasty via intermuscular space approach

    Procedure/Surgery

    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

  • cervical single-door laminoplasty via the conventional approach

    Procedure/Surgery

    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.

Treatment groups

376 Participants
are divided into 2 treatment groups
Group A: Via the intermuscular spaceExperimental treatment 1 intervention
Group B: ControlSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
2 years after operation

Secondary outcomes

1

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)

Time frame
Before surgery and 1week, 1month, 3months, 6months, 1year after surgery
2

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.

Time frame
Before surgery; 1week, 1month, 3months, 6months, 1year and 2 years after surgery
3

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.

Time frame
Before surgery; 1week, 1month, 3months, 6months, 1year and 2 years after surgery
4

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.

Time frame
Before surgery; 1week, 1month, 3months, 6months, 1year and 2 years after surgery

Other outcomes

1

Incidence of adverse reactions

Safety Metrics Incidence of adverse reactions= (amount of adverse reactions/amount of patients)\*100%

Time frame
1 week, 1month, 3months, 6months, 1year and 2 years after surgery
2

Incidence of adverse events

Safety Metrics Incidence of adverse events= (amount of adverse events/amount of patients)\*100%

Time frame
1 week, 1month, 3months, 6months, 1year and 2 years after surgery
3

Incidence of severe adverse events

Safety Metrics Incidence of severe adverse events= (amount of severe adverse events/amount of patients)\*100%

Time frame
1 week, 1month, 3months, 6months, 1year and 2 years after surgery
4

Mortality

Safety Metrics Mortality= (amount of death/amount of patients)\*100%

Time frame
1 week, 1month, 3months, 6months, 1year and 2 years after surgery

Locations

This trial has no 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

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