Clinical trial NCT00876603: Anterior Vs Posterior Procedures for Cervical Spondylotic Myelopathy: Prospective Randomized Clinical Trial
Official title: A Comparison of Anterior and Posterior Procedures for the Surgical Management of Cervical Spondylotic Myelopathy: Prospective Randomized Clinical Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Spondylotic Myelopathy
Keywords: cervical spondylotic myelopathy
anterior decompression and fusion
cervical laminoplasty
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2009-04-07
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suffer from cervical spondylotic myelopathy requiring surgery.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Patients with transverse lesion type of cervical myelopathy caused by cervical spondylosis requiring surgery.
* Involved levels limited to 1, 2 and 3 continuous levels

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Japanese Orthopaedic Association Score for Cervical Myelopathy
timeFrame: 3 months, 6 months, 1 year, 3 years, 5 years and 10 years
Secondary outcomes:
measure: 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.
timeFrame: 3 months, 6 months, 1 year, 3 years, 5 years and 10 years
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The Duchess of Kent Children's Hospital
state: Hong Kong
Study officials:
affiliation: Department of Orthopaedics and Traumatology, The University of Hong Kong
name: Wai Yuen Cheung, MBBS, FRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Orthopaedics and Traumatology, The Universityof Hong Kong
name: Keith DK Luk, MBBS, FRCS
role: STUDY_DIRECTOR
affiliation: Department of Orthopaedics and Traumatology, The University of Hong Kong
name: Kenneth MC Cheung, MBBS, FRCS
role: STUDY_DIRECTOR
affiliation: Department of Orthopaedics and Traumatology, The University of Hong Kong.
name: Yat Wa Wong, MBBS, FRCS
role: PRINCIPAL_INVESTIGATOR
References: