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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

376 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-15

Study Completion Date

2035-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cervical Spondylotic Myelopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Via the intermuscular space

Group Type EXPERIMENTAL

Expansive open-door laminoplasty via intermuscular space approach

Intervention Type PROCEDURE

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

Control

Group Type SHAM_COMPARATOR

cervical single-door laminoplasty via the conventional approach

Intervention Type PROCEDURE

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.

Interventions

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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

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No