Clinical trial NCT06941649: Efficacy of Two Approaches in Cervical Single-door Laminoplasty for Spinal Canal Enlargement
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cervical Spondylotic Myelopathy
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of University of South China
name: Guangzhou First People's Hospital
name: The Seventh Affiliated Hospital of Sun Yat-sen University
name: The Third Affiliated Hospital of Southern Medical University
First posted: 2025-04-24
Enrollment: 376
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: modified Japanese Orthopedic Association score
timeFrame: 2 years after operation
Secondary outcomes:
measure: modified Japanese Orthopedic Association Score
timeFrame: Before surgery and 1week, 1month, 3months, 6months, 1year after surgery
measure: Cervical Visual Analogue Scale Score
timeFrame: Before surgery; 1week, 1month, 3months, 6months, 1year and 2 years after surgery
measure: Zeng's axial symptom scale
timeFrame: Before surgery; 1week, 1month, 3months, 6months, 1year and 2 years after surgery
measure: Hosono axial symptom scale
timeFrame: Before surgery; 1week, 1month, 3months, 6months, 1year and 2 years after surgery
measure: Cervical 11-point Numerical Rating Scale
timeFrame: Before surgery; 1week, 1month, 3months, 6months, 1year and 2 years after surgery
Other outcomes:
measure: Incidence of adverse reactions
timeFrame: 1 week, 1month, 3months, 6months, 1year and 2 years after surgery
measure: Incidence of adverse events
timeFrame: 1 week, 1month, 3months, 6months, 1year and 2 years after surgery
measure: Incidence of severe adverse events
timeFrame: 1 week, 1month, 3months, 6months, 1year and 2 years after surgery
measure: Mortality
timeFrame: 1 week, 1month, 3months, 6months, 1year and 2 years after surgery
Locations:
Study officials:
References: