Cervical Laminoplasty Versus Laminectomy and Fusion: the Long-term Results Comparison

• Conditions: Myelopathy Cervical

• Registration Number: NCT04559672
• Lead Sponsor: Shanghai Changzheng Hospital

Brief Summary

The objective of this study is to retrospectively analyze and compare the long-term clinical and radiographic results of multi-level laminoplasty to multi-level laminectomy and fusion for the treatment of patients with cervical myelopathy or myeloradiculopathy.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01-01
• Study First Submitted: 2020-09-13
• Study First Submitted QC: 2020-09-16
• Study First Posted: 2020-09-23
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-04
• Last Update Posted: 2022-05-05
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients aged at least 18 years
• The patient has the diagnosis of degenerative cervical myelopathy
• The myelopathy or myeloradiculopathy requires a posterior cervical decompression of the spinal canal involving two or more contiguous intervertebral levels including and between C3 and C7
• More than five years of follow-up time

Exclusion Criteria

• Presence of primary focal anterior compression of the cervical spinal cord
• Previous surgery of the cervical spine
• Tumor, infection, or trauma of the cervical spine or cord
• Patients with ankylosing spondylitis
• Patients with neurodegenerative diseases, or any neuropathies

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of Sagittal Lordosis Angle	baseline, 12 months post-treatment and through study completion, an average of 10 year	Measured by lateral X-Ray image. The change of lordosis was calculated and compared.
Reoperation rate	through study completion, an average of 10 year	Any reoperation involving the same segments or adjacent segments will be calculated.
Change of Neck Disability Index (NDI)	baseline, 12 months post-treatment and through study completion, an average of 10 year	Ranging from 0%-100%. A higher score indicates more patient-rated disability.
Change of Japanese Orthopaedic Association Score (JOA)	baseline, 12 months post-treatment and through study completion, an average of 10 year	Total score 0-17. The lower the score the more severe the deficits.

Secondary Outcome Measures

Name	Time	Method
Change of Range of Motion	baseline, 12 months post-treatment and through study completion, an average of 10 year	Measured by dynamic X-Ray image.
Change of Pain Scores on the Visual Analog Scale (VAS)	baseline, 12 months post-treatment and through study completion, an average of 10 year	Ranging from 0-10. A higher score indicates more severe pain.
Complication rate	through study completion, an average of 10 year	Any complications related to surgery will be recorded.

Trial Locations

Locations (1)

Shanghai Changzheng Hospital; 🇨🇳 Shanghai, China