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

NCT06941649 | Not Yet Recruiting DMC

• 1 other identifier: SYSKY-2025-099-01
• Study Type: interventional
• Target: 376
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cervical Spondylotic Myelopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• modified Japanese Orthopedic Association Score

  Before surgery and 1week, 1month, 3months, 6months, 1year after surgery

• Cervical Visual Analogue Scale Score

  Before surgery; 1week, 1month, 3months, 6months, 1year and 2 years after surgery

• Zeng's axial symptom scale

  Before surgery; 1week, 1month, 3months, 6months, 1year and 2 years after surgery

• Hosono axial symptom scale

  Before surgery; 1week, 1month, 3months, 6months, 1year and 2 years after surgery

• Cervical 11-point Numerical Rating Scale

  Before surgery; 1week, 1month, 3months, 6months, 1year and 2 years after surgery

Other Outcomes (4)

• Incidence of adverse reactions

  1 week, 1month, 3months, 6months, 1year and 2 years after surgery

• Incidence of adverse events

  1 week, 1month, 3months, 6months, 1year and 2 years after surgery

• Incidence of severe adverse events

  1 week, 1month, 3months, 6months, 1year and 2 years after surgery

Study Arms (2)

Via the intermuscular space

EXPERIMENTAL

Procedure: Expansive open-door laminoplasty via intermuscular space approach

Control

SHAM COMPARATOR

Procedure: cervical single-door laminoplasty via the conventional approach

Interventions

Expansive open-door laminoplasty via intermuscular space approach 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

Via the intermuscular space

cervical single-door laminoplasty via the conventional approach 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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: April 24, 2025
• Study Start: April 15, 2025
• Primary Completion (Estimated): December 31, 2035
• Study Completion (Estimated): December 31, 2035
• Last Updated: April 24, 2025

Record last verified: 2025-04