Cervical Spondylotic MyelopathyNCT06941649
Efficacy of Two Approaches in Cervical Single-door Laminoplasty for Spinal Canal Enlargement
A study testing Expansive open-door laminoplasty via intermuscular space approach and cervical single-door laminoplasty via the conventional approach in people with Cervical Spondylotic Myelopathy, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Spondylotic Myelopathy
- What is being tested?
- Expansive open-door laminoplasty via intermuscular space approach and cervical single-door laminoplasty via the conventional approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 376 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2025to 31 Dec 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18
- Patients with cervical spondylotic myelopathy meeting surgery indications.
- Sign informed consent
Who cannot join
- 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
Show all 9Show fewer
- 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
About this study
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
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.
Read more
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
- Being tested
- Expansive open-door laminoplasty via intermuscular space approach, cervical single-door laminoplasty via the conventional approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expansive open-door laminoplasty via intermuscular space approachProcedure or surgery
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
cervical single-door laminoplasty via the conventional approachProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Via the intermuscular space | Experimental | Not described Receives: Procedure: Expansive open-door laminoplasty via intermuscular space approach |
| Control | Sham comparator | Not described Receives: Procedure: cervical single-door laminoplasty via the conventional approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Japanese Orthopedic Association score
Evaluate neurological function in 4 dimension with a total of 18 points:
- Upper limb motor dysfunction(5 points) B. Lower limb motor dysfunction(7 points) C. Sensory dysfunction(3 points) D. Sphincter dysfunction(3 points)
Measured: 2 years after operation
Secondary outcomes (5)
modified Japanese Orthopedic Association Score
Evaluate neurological function in 4 dimension with a total of 18 points:
- Upper limb motor dysfunction(5 points) B. Lower limb motor dysfunction(7 points) C. Sensory dysfunction(3 points) D. Sphincter dysfunction(3 points)
Measured: Before surgery and 1week, 1month, 3months, 6months, 1year after surgery
Cervical Visual Analogue Scale Score
According to the severity of patient's neck pain, on a scale of 1-10, let patients themselves choose one score.
0 means no pain and 10 means extreme pain.
Measured: Before surgery; 1week, 1month, 3months, 6months, 1year and 2 years after surgery
Zeng's axial symptom scale
Based on the impact on work and life, and objective examination of neck paraspinal muscles and trapezius for spasms and tenderness, divided into 4 grades:
- "Excellent": No abnormal sensations in the neck, no tenderness or muscle spasms;
- "Good": Mild symptoms after fatigue or cold exposure, but quick recovery, no significant impact on daily work and life, no tenderness or mild spasms in neck muscles, no need for painkillers;
- "Fair": Symptoms often appear <100 days/year, daily work and life are somewhat affected, mild tenderness or spasms in neck muscles, need for painkillers with good effect;
- "Poor": Symptoms frequent (>100 days/year), significantly affecting daily work and life, obvious tenderness or spasms in neck muscles, need for painkillers with poor effect.
Those rated as excellent and good are considered to have no axial symptoms, while those rated as fair and poor are considered to have axial symptoms, and the incidence is calculated.
Measured: Before surgery; 1week, 1month, 3months, 6months, 1year and 2 years after surgery
Hosono axial symptom scale
According to patients' axial symptom and which treatment can alleviate it:
Severe (regular need for analgesics or local injections), Moderate (regular need for physical therapy or compression), or Mild (no need for treatment). Severe and moderate are defined as having axial symptoms, while mild is defined as having no axial symptoms.
Measured: Before surgery; 1week, 1month, 3months, 6months, 1year and 2 years after surgery
Cervical 11-point Numerical Rating Scale
Based on neck symptoms, ask the patient to rate their condition on a scale from 0 to 10, where 0 indicates no symptoms and 10 indicates severe symptoms
Measured: Before surgery; 1week, 1month, 3months, 6months, 1year and 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start15 Apr 2025 (estimated)
- Primary completion31 Dec 2035 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Spondylotic MyelopathyStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 376 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of University of South China, Guangzhou First People's Hospital, The Seventh Affiliated Hospital of Sun Yat-sen University, The Third Affiliated Hospital of Southern Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06941649
- Sponsor's protocol ID
- SYSKY-2025-099-01
- Status last verified
- Apr 2025
- First submitted
- 19 Mar 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06941649
- Acronym / sponsor ID
- SYSKY-2025-099-01
- Conditions
- Cervical Spondylotic Myelopathy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 376 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of University of South China, Guangzhou First People's Hospital, The Seventh Affiliated Hospital of Sun Yat-sen University, The Third Affiliated Hospital of Southern Medical University
- Study start
- 15 Apr 2025 (estimated)
- Primary completion
- 31 Dec 2035 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18
- Patients with cervical spondylotic myelopathy meeting surgery indications.
- Sign informed consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expansive open-door laminoplasty via intermuscular space approachThe 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 or surgery | Via the intermuscular space |
| cervical single-door laminoplasty via the conventional approachThe 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. | Procedure or surgery | Control |
Primary outcome
modified Japanese Orthopedic Association score
Time frame: 2 years after operation
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)
5 secondary outcomes
modified Japanese Orthopedic Association Score
Time frame: Before surgery and 1week, 1month, 3months, 6months, 1year after surgery
Cervical Visual Analogue Scale Score
Time frame: Before surgery; 1week, 1month, 3months, 6months, 1year and 2 years after surgery
Zeng's axial symptom scale
Time frame: Before surgery; 1week, 1month, 3months, 6months, 1year and 2 years after surgery
Hosono axial symptom scale
Time frame: Before surgery; 1week, 1month, 3months, 6months, 1year and 2 years after surgery
Cervical 11-point Numerical Rating Scale
Time frame: Before surgery; 1week, 1month, 3months, 6months, 1year and 2 years after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Expansive open-door laminoplasty via intermuscular space approach and cervical single-door laminoplasty via the conventional approach in people with Cervical Spondylotic Myelopathy, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Japanese Orthopedic Association score (time frame: 2 years after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.