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

Myelopathy Cervical Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04559672
• Other study ID #: CZ2020091101
• Status: Recruiting
• Start date: January 1, 2005
• Est. completion date: June 1, 2023

Study information

• Verified date: May 2022
• Source: Shanghai Changzheng Hospital
• Contact: Xuhua Lu, M.D.
• Phone: +862181885793
• Email: xuhualu[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Myelopathy Cervical
• Spinal Cord Diseases

Intervention

Procedure:
• Cervical laminoplasty surgery
The posterior standard cervical laminoplasty procedure with ARCH mini-plate fixation
• Cervical laminectomy and fusion surgery
The posterior standard cervical laminectomy and fusion surgery procedure with lateral mass screws fixation

Locations

Country	Name	City	State
China	Shanghai Changzheng Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Changzheng Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Japanese Orthopaedic Association Score (JOA)	Total score 0-17. The lower the score the more severe the deficits.	baseline, 12 months post-treatment and through study completion, an average of 10 year
Primary	Change of Neck Disability Index (NDI)	Ranging from 0%-100%. A higher score indicates more patient-rated disability.	baseline, 12 months post-treatment and through study completion, an average of 10 year
Primary	Change of Sagittal Lordosis Angle	Measured by lateral X-Ray image. The change of lordosis was calculated and compared.	baseline, 12 months post-treatment and through study completion, an average of 10 year
Primary	Reoperation rate	Any reoperation involving the same segments or adjacent segments will be calculated.	through study completion, an average of 10 year
Secondary	Change of Pain Scores on the Visual Analog Scale (VAS)	Ranging from 0-10. A higher score indicates more severe pain.	baseline, 12 months post-treatment and through study completion, an average of 10 year
Secondary	Change of Range of Motion	Measured by dynamic X-Ray image.	baseline, 12 months post-treatment and through study completion, an average of 10 year
Secondary	Complication rate	Any complications related to surgery will be recorded.	through study completion, an average of 10 year