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Clinical Trials/NCT04559672
NCT04559672
Unknown
Not Applicable

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

Shanghai Changzheng Hospital1 site in 1 country60 target enrollmentStarted: January 1, 2005Last updated:

Overview

Phase
Not Applicable
Enrollment
60
Locations
1
Primary Endpoint
Change of Sagittal Lordosis Angle

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Change of Sagittal Lordosis Angle

Time Frame: 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

Time Frame: 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)

Time Frame: 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)

Time Frame: 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 Outcomes

  • Change of Range of Motion(baseline, 12 months post-treatment and through study completion, an average of 10 year)
  • Change of Pain Scores on the Visual Analog Scale (VAS)(baseline, 12 months post-treatment and through study completion, an average of 10 year)
  • Complication rate(through study completion, an average of 10 year)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Xuhua Lu

Director of Traumatic Orthopaedic Department

Shanghai Changzheng Hospital

Study Sites (1)

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