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

Study Overview
=================
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.

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

Conditions
-----------------
Myelopathy Cervical

Intervention / Treatment
-----------------
* Procedure: Cervical laminoplasty surgery
* Procedure: Cervical laminectomy and fusion surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Laminoplasty Group<br>Patients who underwent cervical laminoplasty surgery due to myelopathy. | Procedure: Cervical laminoplasty surgery<br>* The posterior standard cervical laminoplasty procedure with ARCH mini-plate fixation<br>|
| Laminectomy and Fusion Group<br>Patients who underwent cervical laminectomy and fusion surgery due to myelopathy. | Procedure: Cervical laminectomy and fusion surgery<br>* The posterior standard cervical laminectomy and fusion surgery procedure with lateral mass screws fixation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Reoperation rate | Any reoperation involving the same segments or adjacent segments will be calculated. | through study completion, an average of 10 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Complication rate | Any complications related to surgery will be recorded. | through study completion, an average of 10 year |