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

NCT06941649 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 376

Last updated 2025-04-24

No results posted yet for this study

Summary

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.

Conditions

  • Cervical Spondylotic Myelopathy

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.

Sponsors & Collaborators

  • The First Affiliated Hospital of University of South China

    collaborator OTHER

  • Guangzhou First People's Hospital

    collaborator OTHER

  • The Seventh Affiliated Hospital of Sun Yat-sen University

    collaborator OTHER

  • The Third Affiliated Hospital of Southern Medical University

    collaborator OTHER_GOV

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-15
Primary Completion
2035-12-31
Completion
2035-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06941649 on ClinicalTrials.gov