NCT00876603

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2001

Completed
7.9 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 7, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

January 14, 2010

Status Verified

January 1, 2010

Enrollment Period

9.6 years

First QC Date

April 6, 2009

Last Update Submit

January 12, 2010

Conditions

Cervical Spondylotic Myelopathy

Keywords

cervical spondylotic myelopathyanterior decompression and fusioncervical laminoplasty

Outcome Measures

Primary Outcomes (1)

  • Japanese Orthopaedic Association Score for Cervical Myelopathy

    3 months, 6 months, 1 year, 3 years, 5 years and 10 years

Secondary Outcomes (1)

  • 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.

    3 months, 6 months, 1 year, 3 years, 5 years and 10 years

Study Arms (4)

1

2

CSM - ACDF

Cervical spondylotic myelopathy treated with anterior cervical decompression and fusion

Procedure: ACDF

CSM - Cervical laminoplasty

Cervical spondylotic myelopathy treated with cervical laminoplasty

Procedure: Cervical laminoplasty

Interventions

ACDFPROCEDURE

Anterior cervical decompression and fusion

CSM - ACDF
Cervical laminoplastyPROCEDURE

Cervical laminoplasty

CSM - Cervical laminoplasty

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients suffer from cervical spondylotic myelopathy requiring surgery.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Duchess of Kent Children's Hospital

Hong Kong, Hong Kong, China

RECRUITING

Study Officials

  • Wai Yuen Cheung, MBBS, FRCS

    Department of Orthopaedics and Traumatology, The University of Hong Kong

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY DIRECTOR

  • Yat Wa Wong, MBBS, FRCS

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wai Yuen Cheung, MBBS, FRCS

CONTACT

(852) 28554111lcheung@hkucc.hku.hk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 6, 2009

First Posted

April 7, 2009

Study Start

May 1, 2001

Primary Completion

December 1, 2010

Study Completion

December 1, 2020

Last Updated

January 14, 2010

Record last verified: 2010-01

Locations

CN(1)