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

Sponsor
Shanghai Changzheng Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04559672
Collaborator
(none)
60
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220.9
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Cervical laminoplasty surgery
  • Procedure: Cervical laminectomy and fusion surgery

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Cervical Laminoplasty Versus Laminectomy and Fusion: the Long-term Results Comparison
Actual Study Start Date :
Jan 1, 2005
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Laminoplasty Group

Patients who underwent cervical laminoplasty surgery due to myelopathy.

Procedure: Cervical laminoplasty surgery
The posterior standard cervical laminoplasty procedure with ARCH mini-plate fixation

Laminectomy and Fusion Group

Patients who underwent cervical laminectomy and fusion surgery due to myelopathy.

Procedure: Cervical laminectomy and fusion surgery
The posterior standard cervical laminectomy and fusion surgery procedure with lateral mass screws fixation

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. Reoperation rate [through study completion, an average of 10 year]

    Any reoperation involving the same segments or adjacent segments will be calculated.

Secondary Outcome Measures

  1. 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.

  2. 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.

  3. Complication rate [through study completion, an average of 10 year]

    Any complications related to surgery will be recorded.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shanghai Changzheng Hospital Shanghai China 200003

Sponsors and Collaborators

  • Shanghai Changzheng Hospital

Investigators

  • Principal Investigator: Xuhua Lu, M.D., Shanghai Changzheng Hospotal

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xuhua Lu, Director of Traumatic Orthopaedic Department, Shanghai Changzheng Hospital
ClinicalTrials.gov Identifier:
NCT04559672
Other Study ID Numbers:
  • CZ2020091101
First Posted:
Sep 23, 2020
Last Update Posted:
May 5, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 5, 2022