Comparison Between C3-6 Laminoplasty and C3 Laminectomy With Cervical Laminoplasty

January 9, 2024 updated by: Chun Kee Chung, Seoul National University Hospital

Randomized Controlled Trial: Comparison of Radiological and Axial Pain Outcome Between C3-6 Open Door Laminoplasty and C3 Laminectomy With Cervical Laminoplasty

Investigators performed a prospective randomized controlled trial for comparing postoperative clinical and radiological outcomes between C3 laminectomy with laminoplasty and C3-6 laminoplasty.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cervical laminoplasty is widely performed surgical techniques to cervical myelopathy patients. But it is well known that C3-6 Cervical laminoplasty often results in injury of the semispinalis cervicis inserted into the axis, which possibly causes postoperative cervical kyphosis and neck pain. C3 laminectomy with cervical laminoplasty is the modified technique preserving the semispinalis cervicis to reduce such complications of conventional C3-6 laminoplasty.

There has been a number of retrospective studies comparing C3 laminectomy with laminoplasty and C3-6 laminoplasty, however, there's no prospective randomized controlled study yet. Investigators performed a prospective randomized controlled trial for comparing postoperative clinical and radiological outcomes between C3 laminectomy with laminoplasty and C3-6 laminoplasty. Primary end points include the C2-7 spine cobb anlge, Neck Disability Index(NDI) at postoperative 1~3 year

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Korea, Republic of
    • Korea
      • Seoul, Korea, Korea, Republic of, 03080
        • Seoul National University Hospital

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 to 96 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Cervical stenosis patients with or without cervical myelopathy.

Exclusion Criteria:

  • Metastatic cancer patients.
  • Any combined fracture.
  • Previous surgery to cervical spine.
  • inflammatory joint disease
  • psychiatric illness

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: C3 laminectomy with C4-6 laminoplasty
Cervical myelopathy patients who underwent C3 laminectomy with laminoplasty.
Procedure: C3 laminectomy
C3 laminectomy preserving semispinalis cervicis inserted into the axis.
Active Comparator: C3-6 laminoplasty
Cervical myelopathy patients who underwent C3-6 laminoplasty.
Procedure: C3 laminoplasty
Conventional C3-6 laminoplasty, resulting in injury of semispinalis cervicis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
C2-C7 Lordosis
Time Frame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
Measuring C2-C7 lordosis angle by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked.
at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
the Neck Disability Index (NDI)
Time Frame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
scores from 0 to 50 with 50 being the worst performance status related to neck pain.
at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
C2-C3 Lordosis
Time Frame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
Measuring C2-C3 lordosis by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked.
at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
C4-C7 Lordosis
Time Frame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
Measuring C4-C7 lordosis by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked.
at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
Cervical Sagittal Vertical Axis (cSVA)
Time Frame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
Measuring cervical sagittal vertical axis by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked.
at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
T1 Slope
Time Frame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
Measuring T1 slope by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked.
at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
T1 Slope Minus Cervical Lordosis
Time Frame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
Measuring T1 slope minus cervical lordosis by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked.
at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
C2-C3 Interlaminar Spontaneous Fusion
Time Frame: at 2 year
Measuring the incidence of postoperative C2-C3 interlaminar spontaneous fusion by using standard lateral cervical x-ray series.
at 2 year
EuroQol Five-dimensional Questionnaire (EQ-5D) Scores
Time Frame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
Responses on a questionnaire with five dimensions, each comprised of five levels. Scores are revised into an index with a range from -0.59-1, with 1.00 indicating full health. The 243 possible health states on the EQ-5D are evaluated against a normal population using the time trade off method (TTO).
at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
Posterior Neck With Numering Rating Scale (NRS-N)
Time Frame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
Measuring pain intensity of the posterior neck with numeric rating scale (NRS), rated 1 to 10 with 10 being the most severe pain level.
at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
Upper Limb Pain With Numering Rating Scale (NRS-L)
Time Frame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
Measuring pain intensity of the upper limb with numeric rating scale (NRS), rated 1 to 10 with 10 being the most severe pain level.
at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
Estimated Intraoperative Blood Loss
Time Frame: Intraoperative
Measuring estimated intraoperative blood loss by using intraoperative records of anesthesiologists.
Intraoperative
Operative Time
Time Frame: Intraoperative
Measuring the time between start of the surgery (incision) and the finish of surgery (closure of the skin).
Intraoperative

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Investigators

  • Study Chair: Chun Kee Chung, MD, PhD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 20, 2017

Primary Completion (Actual)

October 28, 2022

Study Completion (Actual)

October 28, 2022

Study Registration Dates

First Submitted

July 30, 2021

First Submitted That Met QC Criteria

August 8, 2021

First Posted (Actual)

August 16, 2021

Study Record Updates

Last Update Posted (Actual)

June 21, 2024

Last Update Submitted That Met QC Criteria

January 9, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1610-136-804

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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