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

January 12, 2010 updated by: The University of Hong Kong

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hong Kong
      • Hong Kong, Hong Kong, China
        • Recruiting
        • The Duchess of Kent Children's Hospital
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients suffer from cervical spondylotic myelopathy requiring surgery.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
2
CSM - ACDF
Cervical spondylotic myelopathy treated with anterior cervical decompression and fusion
Procedure: ACDF
Anterior cervical decompression and fusion
CSM - Cervical laminoplasty
Cervical spondylotic myelopathy treated with cervical laminoplasty
Procedure: Cervical laminoplasty
Cervical laminoplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Japanese Orthopaedic Association Score for Cervical Myelopathy
Time Frame: 3 months, 6 months, 1 year, 3 years, 5 years and 10 years
3 months, 6 months, 1 year, 3 years, 5 years and 10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
3 months, 6 months, 1 year, 3 years, 5 years and 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2001

Primary Completion (ANTICIPATED)

December 1, 2010

Study Completion (ANTICIPATED)

December 1, 2020

Study Registration Dates

First Submitted

April 6, 2009

First Submitted That Met QC Criteria

April 6, 2009

First Posted (ESTIMATE)

April 7, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

January 14, 2010

Last Update Submitted That Met QC Criteria

January 12, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A Vs P Decompression for CSM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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