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

Sun Yat-sen University

Status: Not yet enrolling

Conditions: Cervical Spondylotic Myelopathy

Treatments: Procedure: cervical single-door laminoplasty via the conventional approach; Procedure: Expansive open-door laminoplasty via intermuscular space approach

Study type: Interventional

Funder types: Other

Identifiers

NCT06941649

SYSKY-2025-099-01

Details and patient eligibility

About

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.

Enrollment: 376 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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376 participants in 2 patient groups

Via the intermuscular space

Experimental group

Treatment:

Procedure: Expansive open-door laminoplasty via intermuscular space approach

Control

Sham Comparator group

Treatment:

Procedure: cervical single-door laminoplasty via the conventional approach