Cervical Laminoplasty Versus Laminectomy and Fusion: the Long-term Results Comparison
1 other identifier
observational
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2005
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2020
CompletedFirst Posted
Study publicly available on registry
September 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedMay 5, 2022
May 1, 2022
18.4 years
September 13, 2020
May 4, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (3)
Change of Pain Scores on the Visual Analog Scale (VAS)
baseline, 12 months post-treatment and through study completion, an average of 10 year
Change of Range of Motion
baseline, 12 months post-treatment and through study completion, an average of 10 year
Complication rate
through study completion, an average of 10 year
Study Arms (2)
Laminoplasty Group
Patients who underwent cervical laminoplasty surgery due to myelopathy.
Laminectomy and Fusion Group
Patients who underwent cervical laminectomy and fusion surgery due to myelopathy.
Interventions
The posterior standard cervical laminoplasty procedure with ARCH mini-plate fixation
The posterior standard cervical laminectomy and fusion surgery procedure with lateral mass screws fixation
Eligibility Criteria
Patients who underwent cervical laminoplasty or laminectomy and fusion surgery due to degenerative cervical myelopathy in our hospital from January 1, 2005 to January 1, 2015 were screened and included according to the eligibility criteria.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Changzheng Hospital
Shanghai, 200003, China
Study Officials
- PRINCIPAL INVESTIGATOR
Xuhua Lu, M.D.
Shanghai Changzheng Hospotal
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Traumatic Orthopaedic Department
Study Record Dates
First Submitted
September 13, 2020
First Posted
September 23, 2020
Study Start
January 1, 2005
Primary Completion
June 1, 2023
Study Completion
June 1, 2023
Last Updated
May 5, 2022
Record last verified: 2022-05