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

Cervical Spondylotic Myelopathy Clinical Trial

— CSM  

Official title:

A Comparison of Anterior and Posterior Procedures for the Surgical Management of Cervical Spondylotic Myelopathy: Prospective Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00876603
• Other study ID #: A Vs P Decompression for CSM
• Status: Recruiting
• Phase: N/A
• First received: April 6, 2009
• Last updated: January 12, 2010
• Start date: May 2001
• Est. completion date: December 2020

Study information

• Verified date: January 2010
• Source: The University of Hong Kong
• Contact: Wai Yuen Cheung, MBBS, FRCS
• Phone: (852) 28554111
• Email: lcheung[@]hkucc.hku.hk
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2020
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Cervical Spondylotic Myelopathy

Intervention

Procedure:
• ACDF
Anterior cervical decompression and fusion
• Cervical laminoplasty
Cervical laminoplasty

Locations

Country	Name	City	State
China	The Duchess of Kent Children's Hospital	Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Japanese Orthopaedic Association Score for Cervical Myelopathy		3 months, 6 months, 1 year, 3 years, 5 years and 10 years	No
Secondary	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	No