Anterior Vs Posterior Procedures for Cervical Spondylotic Myelopathy: Prospective Randomized Clinical Trial

NCT ID: NCT00876603

Last Updated: 2010-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-05-31

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Cervical Spondylotic Myelopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

No interventions assigned to this group

2

No interventions assigned to this group

CSM - ACDF

Cervical spondylotic myelopathy treated with anterior cervical decompression and fusion

ACDF

Intervention Type PROCEDURE

Anterior cervical decompression and fusion

CSM - Cervical laminoplasty

Cervical spondylotic myelopathy treated with cervical laminoplasty

Cervical laminoplasty

Intervention Type PROCEDURE

Cervical laminoplasty

Interventions

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ACDF

Anterior cervical decompression and fusion

Intervention Type PROCEDURE

Cervical laminoplasty

Cervical laminoplasty

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Department of Orthopaedics and Traumatology, The University of Hong Kong.

Principal Investigators

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Wai Yuen Cheung, MBBS, FRCS

Role: PRINCIPAL_INVESTIGATOR

Department of Orthopaedics and Traumatology, The University of Hong Kong

Keith DK Luk, MBBS, FRCS

Role: STUDY_DIRECTOR

Department of Orthopaedics and Traumatology, The Universityof Hong Kong

Kenneth MC Cheung, MBBS, FRCS

Role: STUDY_DIRECTOR

Department of Orthopaedics and Traumatology, The University of Hong Kong

Yat Wa Wong, MBBS, FRCS

Role: PRINCIPAL_INVESTIGATOR

Department of Orthopaedics and Traumatology, The University of Hong Kong.

Locations

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The Duchess of Kent Children's Hospital

Hong Kong, Hong Kong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wai Yuen Cheung, MBBS, FRCS

Role: CONTACT

(852) 28554111 ext. 3825

Facility Contacts

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Wai Yuen Cheung, MBBS, FRCS

Role: primary

(852) 28554111 ext. 3825

Other Identifiers

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A Vs P Decompression for CSM

Identifier Type: -

Identifier Source: org_study_id

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