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Sponsored by: |
The University of Hong Kong |
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Information provided by: | The University of Hong Kong |
ClinicalTrials.gov Identifier: | NCT00876603 |
There is no difference in surgical outcomes for patients suffering from cervical spondylotic myelopathy treated with anterior decompression and fusion or posterior cervical laminoplasty.
Condition | Intervention |
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Cervical Spondylotic Myelopathy |
Procedure: ACDF Procedure: Cervical laminoplasty |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | A Comparison of Anterior and Posterior Procedures for the Surgical Management of Cervical Spondylotic Myelopathy: Prospective Randomized Clinical Trial |
Estimated Enrollment: | 100 |
Study Start Date: | May 2001 |
Estimated Study Completion Date: | December 2020 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1 | |
2 | |
CSM - ACDF
Cervical spondylotic myelopathy treated with anterior cervical decompression and fusion
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Procedure: ACDF
Anterior cervical decompression and fusion
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CSM - Cervical laminoplasty
Cervical spondylotic myelopathy treated with cervical laminoplasty
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Procedure: Cervical laminoplasty
Cervical laminoplasty
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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.
Ages Eligible for Study: | 40 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Patients suffer from cervical spondylotic myelopathy requiring surgery.
Inclusion Criteria:
Exclusion Criteria:
Contact: Wai Yuen Cheung, MBBS, FRCS | (852) 28554111 ext 3825 | lcheung@hkucc.hku.hk |
China | |
The Duchess of Kent Children's Hospital | Recruiting |
Hong Kong, China | |
Contact: Wai Yuen Cheung, MBBS, FRCS (852) 28554111 ext 3825 lcheung@hkucc.hku.hk | |
Sub-Investigator: Wai Yuen Cheung, MBBS, FRCS | |
Principal Investigator: Keith DK Luk, MBBS, FRCS | |
Sub-Investigator: Kenneth MC Cheung, MBBS, FRCS | |
Sub-Investigator: Yat Wa Wong, MBBS, FRCS |
Principal Investigator: | Wai Yuen Cheung, MBBS, FRCS | Department of Orthopaedics and Traumatology, The University of Hong Kong |
Study Director: | Keith DK Luk, MBBS, FRCS | Department of Orthopaedics and Traumatology, The Universityof Hong Kong |
Study Director: | Kenneth MC Cheung, MBBS, FRCS | Department of Orthopaedics and Traumatology, The University of Hong Kong |
Principal Investigator: | Yat Wa Wong, MBBS, FRCS | Department of Orthopaedics and Traumatology, The University of Hong Kong. |
Responsible Party: | Department of Orthopaedics and Traumatology, The University of Hong Kong. ( Professor Keith DK Luk. ) |
Study ID Numbers: | A Vs P Decompression for CSM |
Study First Received: | April 6, 2009 |
Last Updated: | April 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00876603 History of Changes |
Health Authority: | Hong Kong: Ethics Committee |
cervical spondylotic myelopathy anterior decompression and fusion cervical laminoplasty |
Spinal Cord Diseases Central Nervous System Diseases |
Spinal Cord Diseases Nervous System Diseases Central Nervous System Diseases |