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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2010 by The University of Hong Kong
Sponsor:
Information provided by:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00876603
First received: April 6, 2009
Last updated: January 12, 2010
Last verified: January 2010
  Purpose

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
Cervical Spondylotic Myelopathy
Procedure: ACDF
Procedure: Cervical laminoplasty

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Comparison of Anterior and Posterior Procedures for the Surgical Management of Cervical Spondylotic Myelopathy: Prospective Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • Japanese Orthopaedic Association Score for Cervical Myelopathy [ Time Frame: 3 months, 6 months, 1 year, 3 years, 5 years and 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

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
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

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

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients suffer from cervical spondylotic myelopathy requiring surgery.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00876603

Contacts
Contact: Wai Yuen Cheung, MBBS, FRCS (852) 28554111 ext 3825 lcheung@hkucc.hku.hk

Locations
China, Hong Kong
The Duchess of Kent Children's Hospital Recruiting
Hong Kong, 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         
Sponsors and Collaborators
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.
  More Information

No publications provided

Responsible Party: Professor Keith DK Luk., Department of Orthopaedics and Traumatology, The University of Hong Kong.
ClinicalTrials.gov Identifier: NCT00876603     History of Changes
Other Study ID Numbers: A Vs P Decompression for CSM
Study First Received: April 6, 2009
Last Updated: January 12, 2010
Health Authority: Hong Kong: Ethics Committee

Keywords provided by The University of Hong Kong:
cervical spondylotic myelopathy
anterior decompression and fusion
cervical laminoplasty

Additional relevant MeSH terms:
Bone Marrow Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014