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Not yet recruiting NCT06941649

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

No phase Interventional Cervical Spondylotic Myelopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Expansive open-door laminoplasty via intermuscular space approach, cervical single-door laminoplasty via the conventional approach.
Who it may be relevant to
Registry conditions: Cervical Spondylotic Myelopathy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

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.

Interventions

  • 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
  • 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.

Primary outcome measures

  • modified Japanese Orthopedic Association score [Time frame: 2 years after operation]
Secondary outcome measures (5)
  • modified Japanese Orthopedic Association Score [Time frame: Before surgery and 1week, 1month, 3months, 6months, 1year after surgery]
  • Cervical Visual Analogue Scale Score [Time frame: Before surgery; 1week, 1month, 3months, 6months, 1year and 2 years after surgery]
  • Zeng's axial symptom scale [Time frame: Before surgery; 1week, 1month, 3months, 6months, 1year and 2 years after surgery]
  • Hosono axial symptom scale [Time frame: Before surgery; 1week, 1month, 3months, 6months, 1year and 2 years after surgery]
  • Cervical 11-point Numerical Rating Scale [Time frame: Before surgery; 1week, 1month, 3months, 6months, 1year and 2 years after surgery]

Eligibility criteria

Inclusion criteria

  • Age >18
  • Patients with cervical spondylotic myelopathy meeting surgery indications.
  • Sign informed consent

Exclusion criteria

  • 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
  • Combined with obvious cervical kyphosis
  • Combined with cervical fracture, dislocation, etc
  • Combined with cervical spinal infection, arthritis and other pathological changes
  • Combined with tumors of cervical spine or spinal cord.
  • Mental retardation or other causes of limited behavioral ability

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06941649 · SYSKY-2025-099-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗