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

May 4, 2022 updated by: Xuhua Lu, Shanghai Changzheng Hospital
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Shanghai, China, 200003
        • Recruiting
        • Shanghai Changzheng Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, 12 months post-treatment and through study completion, an average of 10 year
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.
baseline, 12 months post-treatment and through study completion, an average of 10 year
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.
baseline, 12 months post-treatment and through study completion, an average of 10 year
Reoperation rate
Time Frame: through study completion, an average of 10 year
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)
Time Frame: 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.
baseline, 12 months post-treatment and through study completion, an average of 10 year
Change of Range of Motion
Time Frame: baseline, 12 months post-treatment and through study completion, an average of 10 year
Measured by dynamic X-Ray image.
baseline, 12 months post-treatment and through study completion, an average of 10 year
Complication rate
Time Frame: through study completion, an average of 10 year
Any complications related to surgery will be recorded.
through study completion, an average of 10 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Changzheng Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2005

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

September 13, 2020

First Submitted That Met QC Criteria

September 16, 2020

First Posted (Actual)

September 23, 2020

Study Record Updates

Last Update Posted (Actual)

May 5, 2022

Last Update Submitted That Met QC Criteria

May 4, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CZ2020091101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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