Cervical Spondylotic MyelopathyCSMNCT00876603
Anterior Vs Posterior Procedures for Cervical Spondylotic Myelopathy: Prospective Randomized Clinical Trial
An observational study of Cervical Spondylotic Myelopathy, run by The University of Hong Kong at 1 site in China.
Trial summary
There is no difference in surgical outcomes for patients suffering from cervical spondylotic myelopathy treated with anterior decompression and fusion or posterior cervical laminoplasty. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Cervical Spondylotic Myelopathy
- What is being tested?
- ACDF and Cervical laminoplasty
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- May 2001to Dec 2020
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffer from cervical spondylotic myelopathy requiring surgery.
Who may be able to join
- Patients with transverse lesion type of cervical myelopathy caused by cervical spondylosis requiring surgery.
- Involved levels limited to 1, 2 and 3 continuous levels
Who cannot join
- Radiculomyelopathy
- Cervical kyphosis
- Cervical myelopathy caused by high energy trauma
- Female > 70 years old or patients with severe osteoporosis
- High anaesthetic risk
- Cervical myelopathy other than transverse type
- Cervical myelopathy caused by ossification of posterior longitudinal ligament or inter-vertebral disc herniation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Duchess of Kent Children's Hospital
Hong Kong, Hong Kong
Wai Yuen Cheung, MBBS, FRCS, (852) 28554111 ext. 3825, lcheung@hkucc.hku.hk
Wai Yuen Cheung, MBBS, FRCS
About this study
Official title: A Comparison of Anterior and Posterior Procedures for the Surgical Management of Cervical Spondylotic Myelopathy: Prospective Randomized Clinical Trial
There is no difference in surgical outcomes for patients suffering from cervical spondylotic myelopathy treated with anterior decompression and fusion or posterior cervical laminoplasty.
Read the detailed description
Cervical spondylotic myelopathy (CSM) is a syndrome consisting of symptoms and signs of cervical spinal cord compression caused by chronic degenerative changes of the cervical spine. CSM is the most serious and disabling condition of cervical spondylosis. Natural history studies showed that most of the CSM patients have a progressive deterioration course and no spontaneous regression occurs. It is suggested that the patients with moderate to severe CSM should be operated as early as possible before neurological deficits are too pronounced.
Although there are many options available for the surgical treatment of cervical spondylotic myelopathy, the choice of surgical approach for CSM is still a controversial issue. Most of the surgeons select the surgical approach based on the number of levels involved and the alignment of the spine. Anterior procedure is generally recommended for patients with compression of less than 3 levels or in patients with kyphotic alignment, while posterior decompression is suggested for three or more levels of compression. Retrospective clinical study however has shown that both anterior and posterior surgeries could produce comparable results. There is no scientific data based on randomized, prospective clinical studies comparing the various surgical alternatives. The existing information does not clearly favor any one single approach or operative option. Since anterior and posterior surgeries carries different risks, it is important to identify the most appropriate surgical procedure that is supported by evidence rather than just by surgeons preference.
The objective of this study is to compare the long-term clinical outcome of anterior approach versus posterior approach in the treatment of cervical myelopathy caused by degenerative disease of the cervical spine.
- Conditions
- Cervical Spondylotic Myelopathy
- Being tested
- ACDF, Cervical laminoplasty
- Keywords
- cervical spondylotic myelopathy, anterior decompression and fusion, cervical laminoplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACDFProcedure or surgery
Anterior cervical decompression and fusion
Cervical laminoplastyProcedure or surgery
Cervical laminoplasty
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described | |
| 2 | Not described | |
| CSM - ACDF | Cervical spondylotic myelopathy treated with anterior cervical decompression and fusion Receives: Procedure: ACDF | |
| CSM - Cervical laminoplasty | Cervical spondylotic myelopathy treated with cervical laminoplasty Receives: Procedure: Cervical laminoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Japanese Orthopaedic Association Score for Cervical Myelopathy
Measured: 3 months, 6 months, 1 year, 3 years, 5 years and 10 years
Secondary outcomes (1)
Motor and sensory functions, gait and hand functions, neck pain, change in cervical alignment, spinal cord signal change on MRI, operative time, blood loss, duration of in-patient stay, post-operative complication, re-operation rate.
Measured: 3 months, 6 months, 1 year, 3 years, 5 years and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2009 (estimated)
- Study startMay 2001
- Primary completionDec 2010 (estimated)
- Study completionDec 2020 (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 The University of Hong KongThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Wai Yuen Cheung, MBBS, FRCS, Principal investigator, Department of Orthopaedics and Traumatology, The University of Hong KongKeith DK Luk, MBBS, FRCS, Study director, Department of Orthopaedics and Traumatology, The Universityof Hong KongKenneth MC Cheung, MBBS, FRCS, Study director, Department of Orthopaedics and Traumatology, The University of Hong KongYat Wa Wong, MBBS, FRCS, Principal investigator, Department of Orthopaedics and Traumatology, The University of Hong Kong.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00876603
- Sponsor's protocol ID
- A Vs P Decompression for CSM
- Acronym
- CSM
- Status last verified
- Jan 2010
- First submitted
- 6 Apr 2009
- Last updated
- 14 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Anterior and Posterior Procedures for the Surgical Management of Cervical Spondylotic Myelopathy: Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00876603
- Acronym / sponsor ID
- CSM / A Vs P Decompression for CSM
- Conditions
- Cervical Spondylotic Myelopathy
- Keywords
- cervical spondylotic myelopathy, anterior decompression and fusion, cervical laminoplasty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- May 2001
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 7 Apr 2009 (estimated)
- 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.
There is no difference in surgical outcomes for patients suffering from cervical spondylotic myelopathy treated with anterior decompression and fusion or posterior cervical laminoplasty.
Detailed description
Cervical spondylotic myelopathy (CSM) is a syndrome consisting of symptoms and signs of cervical spinal cord compression caused by chronic degenerative changes of the cervical spine. CSM is the most serious and disabling condition of cervical spondylosis. Natural history studies showed that most of the CSM patients have a progressive deterioration course and no spontaneous regression occurs. It is suggested that the patients with moderate to severe CSM should be operated as early as possible before neurological deficits are too pronounced.
Although there are many options available for the surgical treatment of cervical spondylotic myelopathy, the choice of surgical approach for CSM is still a controversial issue. Most of the surgeons select the surgical approach based on the number of levels involved and the alignment of the spine. Anterior procedure is generally recommended for patients with compression of less than 3 levels or in patients with kyphotic alignment, while posterior decompression is suggested for three or more levels of compression. Retrospective clinical study however has shown that both anterior and posterior surgeries could produce comparable results. There is no scientific data based on randomized, prospective clinical studies comparing the various surgical alternatives. The existing information does not clearly favor any one single approach or operative option. Since anterior and posterior surgeries carries different risks, it is important to identify the most appropriate surgical procedure that is supported by evidence rather than just by surgeons preference.
The objective of this study is to compare the long-term clinical outcome of anterior approach versus posterior approach in the treatment of cervical myelopathy caused by degenerative disease of the cervical spine.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
| 2 | – | – |
| CSM - ACDF | – | Procedure: ACDFCervical spondylotic myelopathy treated with anterior cervical decompression and fusion |
| CSM - Cervical laminoplasty | – | Procedure: Cervical laminoplastyCervical spondylotic myelopathy treated with cervical laminoplasty |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffer from cervical spondylotic myelopathy requiring surgery.
Key inclusion criteria (2 listed)
- Patients with transverse lesion type of cervical myelopathy caused by cervical spondylosis requiring surgery.
- Involved levels limited to 1, 2 and 3 continuous levels
Key exclusion criteria (7 listed)
- Radiculomyelopathy
- Cervical kyphosis
- Cervical myelopathy caused by high energy trauma
- Female > 70 years old or patients with severe osteoporosis
- High anaesthetic risk
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 |
|---|---|---|
| ACDFAnterior cervical decompression and fusion | Procedure or surgery | CSM - ACDF |
| Cervical laminoplastyCervical laminoplasty | Procedure or surgery | CSM - Cervical laminoplasty |
Primary outcome
Japanese Orthopaedic Association Score for Cervical Myelopathy
Time frame: 3 months, 6 months, 1 year, 3 years, 5 years and 10 years
1 secondary outcome
Motor and sensory functions, gait and hand functions, neck pain, change in cervical alignment, spinal cord signal change on MRI, operative time, blood loss, duration of in-patient stay, post-operative complication, re-operation rate.
Time frame: 3 months, 6 months, 1 year, 3 years, 5 years and 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2010.
Related trials for Cervical Spondylotic Myelopathy
Not yet recruitingObservational study
Biomarkers of Cervical Spondylotic Myelopathy
Cervical Spondylotic Myelopathy
Not yet recruitingObservational study
A Multicenter Registry-Based Study Across the Spectrum of Degenerative Cervical Myelopathy
Degenerative Cervical Myelopathy, Non-myelopathic Degenerative Cervical Cord Compression
Active, not recruiting
Multi-centre Study to Evaluate ACAF Versus Laminoplasty in Treating Cervical Ossification of the Posterior Longitudinal Ligament
Ossification of Posterior Longitudinal Ligament, Cervical Spondylosis With Myelopathy
RecruitingObservational study
Validity of the Turkish Translation of the Modified JOA
Spondylosis, Cervical, Spinal Cord Compression
Active, not recruiting
Cervical Spondylotic Myelopathy Surgical Trial
Cervical Spondylosis With Myelopathy
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.
Wai Yuen Cheung, MBBS, FRCS principal investigator
Department of Orthopaedics and Traumatology, The University of Hong Kong
Keith DK Luk, MBBS, FRCS study director
Department of Orthopaedics and Traumatology, The Universityof Hong Kong
Kenneth MC Cheung, MBBS, FRCS study director
Department of Orthopaedics and Traumatology, The University of Hong Kong
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 Cervical Spondylotic Myelopathy, run by The University of Hong Kong 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 2 inclusion and 7 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 14 Jan 2010. 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 Wai Yuen Cheung, MBBS, FRCS ((852) 28554111 ext. 3825, lcheung@hkucc.hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Japanese Orthopaedic Association Score for Cervical Myelopathy (time frame: 3 months, 6 months, 1 year, 3 years, 5 years and 10 years). 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 14 Jan 2010.