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

Comparison of the Clinical Efficacy of Cervical Single-door Laminoplasty Via the Intermuscular Space Approach and the Conventional Approach: A Multicenter, Prospective Controlled Study

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 Overview

• Status: Not yet recruiting
• Conditions: Cervical Spondylotic Myelopathy
• Intervention / Treatment: Procedure: Expansive open-door laminoplasty via intermuscular space approach; Procedure: cervical single-door laminoplasty via the conventional approach

• Study Type: Interventional
• Enrollment (Estimated): 376
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control	Procedure: cervical 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.
Experimental: Via the intermuscular space	Procedure: Expansive 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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: "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.	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Collaborators: Guangzhou First People's Hospital; The Third Affiliated Hospital of Southern Medical University; The First Affiliated Hospital of University of South China; The Seventh Affiliated Hospital of Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2025
• Primary Completion (Estimated): December 31, 2035
• Study Completion (Estimated): December 31, 2035

Study Registration Dates

• First Submitted: March 19, 2025
• First Submitted That Met QC Criteria: April 22, 2025
• First Posted (Actual): April 24, 2025

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 22, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases
• Other Study ID Numbers: SYSKY-2025-099-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No