Myelopathy CervicalNCT04559672
Cervical Laminoplasty Versus Laminectomy and Fusion: the Long-term Results Comparison
An observational study of Myelopathy Cervical, run by Shanghai Changzheng Hospital at 1 site in China.
Trial summary
The objective of this study is to retrospectively analyze and compare the long-term clinical and radiographic results of multi-level laminoplasty to multi-level laminectomy and fusion for the treatment of patients with cervical myelopathy or myeloradiculopathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelopathy Cervical
- What is being tested?
- Cervical laminoplasty surgery and Cervical laminectomy and fusion surgery
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2005to 1 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients who underwent cervical laminoplasty or laminectomy and fusion surgery due to degenerative cervical myelopathy in our hospital from January 1, 2005 to January 1, 2015 were screened and included according to the eligibility criteria.
Who may be able to join
- Patients aged at least 18 years
- The patient has the diagnosis of degenerative cervical myelopathy
- The myelopathy or myeloradiculopathy requires a posterior cervical decompression of the spinal canal involving two or more contiguous intervertebral levels including and between C3 and C7
- More than five years of follow-up time
Who cannot join
- Presence of primary focal anterior compression of the cervical spinal cord
- Previous surgery of the cervical spine
- Tumor, infection, or trauma of the cervical spine or cord
- Patients with ankylosing spondylitis
- Patients with neurodegenerative diseases, or any neuropathies
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Changzheng Hospital
Shanghai, 200003
Xiaoguang Li, M.D., 86-21-81885045, Chzhhospital@163.com
About this study
The objective of this study is to retrospectively analyze and compare the long-term clinical and radiographic results of multi-level laminoplasty to multi-level laminectomy and fusion for the treatment of patients with cervical myelopathy or myeloradiculopathy.
- Conditions
- Myelopathy Cervical
- Being tested
- Cervical laminoplasty surgery, Cervical laminectomy and fusion surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical laminoplasty surgeryProcedure or surgery
The posterior standard cervical laminoplasty procedure with ARCH mini-plate fixation
Cervical laminectomy and fusion surgeryProcedure or surgery
The posterior standard cervical laminectomy and fusion surgery procedure with lateral mass screws fixation
| Study group | Role | What they receive |
|---|---|---|
| Laminoplasty Group | Patients who underwent cervical laminoplasty surgery due to myelopathy. Receives: Procedure: Cervical laminoplasty surgery | |
| Laminectomy and Fusion Group | Patients who underwent cervical laminectomy and fusion surgery due to myelopathy. Receives: Procedure: Cervical laminectomy and fusion surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Japanese Orthopaedic Association Score (JOA)
Total score 0-17. The lower the score the more severe the deficits.
Measured: baseline, 12 months post-treatment and through study completion, an average of 10 year
Change of Neck Disability Index (NDI)
Ranging from 0%-100%. A higher score indicates more patient-rated disability.
Measured: baseline, 12 months post-treatment and through study completion, an average of 10 year
Change of Sagittal Lordosis Angle
Measured by lateral X-Ray image. The change of lordosis was calculated and compared.
Measured: baseline, 12 months post-treatment and through study completion, an average of 10 year
Reoperation rate
Any reoperation involving the same segments or adjacent segments will be calculated.
Measured: through study completion, an average of 10 year
Secondary outcomes (3)
Change of Pain Scores on the Visual Analog Scale (VAS)
Ranging from 0-10. A higher score indicates more severe pain.
Measured: baseline, 12 months post-treatment and through study completion, an average of 10 year
Change of Range of Motion
Measured by dynamic X-Ray image.
Measured: baseline, 12 months post-treatment and through study completion, an average of 10 year
Complication rate
Any complications related to surgery will be recorded.
Measured: through study completion, an average of 10 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start1 Jan 2005
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelopathy CervicalStudies of the same condition, open and under way.
- More trials run by Shanghai Changzheng HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuhua Lu, Shanghai Changzheng Hospital
- Investigators
- Xuhua Lu, M.D., Principal investigator, Shanghai Changzheng Hospotal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04559672
- Sponsor's protocol ID
- CZ2020091101
- Status last verified
- May 2022
- First submitted
- 13 Sep 2020
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Laminoplasty Versus Laminectomy and Fusion: the Long-term Results Comparison
- ClinicalTrials.gov ID
- NCT04559672
- Acronym / sponsor ID
- CZ2020091101
- Conditions
- Myelopathy Cervical
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Study start
- 1 Jan 2005 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 23 Sep 2020 (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 objective of this study is to retrospectively analyze and compare the long-term clinical and radiographic results of multi-level laminoplasty to multi-level laminectomy and fusion for the treatment of patients with cervical myelopathy or myeloradiculopathy.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laminoplasty Group | – | Procedure: Cervical laminoplasty surgeryPatients who underwent cervical laminoplasty surgery due to myelopathy. |
| Laminectomy and Fusion Group | – | Procedure: Cervical laminectomy and fusion surgeryPatients who underwent cervical laminectomy and fusion surgery due to myelopathy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent cervical laminoplasty or laminectomy and fusion surgery due to degenerative cervical myelopathy in our hospital from January 1, 2005 to January 1, 2015 were screened and included according to the eligibility criteria.
Key inclusion criteria (4 listed)
- Patients aged at least 18 years
- The patient has the diagnosis of degenerative cervical myelopathy
- The myelopathy or myeloradiculopathy requires a posterior cervical decompression of the spinal canal involving two or more contiguous intervertebral levels including and between C3 and C7
- More than five years of follow-up time
Key exclusion criteria (5 listed)
- Presence of primary focal anterior compression of the cervical spinal cord
- Previous surgery of the cervical spine
- Tumor, infection, or trauma of the cervical spine or cord
- Patients with ankylosing spondylitis
- Patients with neurodegenerative diseases, or any neuropathies
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 |
|---|---|---|
| Cervical laminoplasty surgeryThe posterior standard cervical laminoplasty procedure with ARCH mini-plate fixation | Procedure or surgery | Laminoplasty Group |
| Cervical laminectomy and fusion surgeryThe posterior standard cervical laminectomy and fusion surgery procedure with lateral mass screws fixation | Procedure or surgery | Laminectomy and Fusion Group |
Primary outcome
Change of Japanese Orthopaedic Association Score (JOA)
Time frame: baseline, 12 months post-treatment and through study completion, an average of 10 year
Total score 0-17. The lower the score the more severe the deficits.
Change of Neck Disability Index (NDI)
Time frame: baseline, 12 months post-treatment and through study completion, an average of 10 year
Ranging from 0%-100%. A higher score indicates more patient-rated disability.
Change of Sagittal Lordosis Angle
Time frame: baseline, 12 months post-treatment and through study completion, an average of 10 year
Measured by lateral X-Ray image. The change of lordosis was calculated and compared.
Reoperation rate
Time frame: through study completion, an average of 10 year
Any reoperation involving the same segments or adjacent segments will be calculated.
3 secondary outcomes
Change of Pain Scores on the Visual Analog Scale (VAS)
Time frame: baseline, 12 months post-treatment and through study completion, an average of 10 year
Change of Range of Motion
Time frame: baseline, 12 months post-treatment and through study completion, an average of 10 year
Complication rate
Time frame: through study completion, an average of 10 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
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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. This study is not recruiting at the moment.
Xuhua Lu, M.D. principal investigator
Shanghai Changzheng Hospotal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelopathy Cervical, run by Shanghai Changzheng Hospital at 1 site in China.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xuhua Lu, M.D. (+862181885793, xuhualu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Japanese Orthopaedic Association Score (JOA) (time frame: baseline, 12 months post-treatment and through study completion, an average of 10 year). The study lists 4 primary outcomes in all. 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 5 May 2022.