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

N/ANot Yet RecruitingNCT06941649

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University376 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

376

Conditions

Cervical Spondylotic Myelopathy

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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)

Time frame: 2 years after operation

Secondary Outcomes

modified Japanese Orthopedic Association Score

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

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

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

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

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

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