Laminoplasty for Multilevel Cervical Spondylotic Myelopathy Guided by Modified K-line and Modified SC-line in MRI

June 28, 2024 updated by: Jiawei Jiang, Affiliated 2 Hospital of Nantong University

Feasibility and Clinical Applicability of Surgical Segments Choice for Laminoplasty in Multilevel Cervical Spondylotic Myelopathy Guided by Modified K-line and Modified SC-line in MRI

This study intended to investigate the combined Impact of mK-line and mSC-line on the selection of the surgical approach and whether could be used to predict sufficient decompression of cervical spinal cord and clinical outcome in patients after LAMP.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study intended to collect MRI of Patients with Multilevel Cervical Spondylotic Myelopathy. K-line(-) patients can be performed LAMP surgery for better prognosis if mK-line(+) and TypeⅠSC-line in MRI, but there are doubts on TypeⅡ and TypeⅢ. However, there has been no study that investigated the combination role of the mK-line and SC-line in surgical decision making for patients with MCSM. In this study, the investigators defined mK-line as a straight line connecting the midpoints of the anteroposterior canal diameter at cranial and caudal vertebrae of the open-door segment in MRI. Accordingly, the investigators propose a modified spinal cord line(mSC-line) that is a straight line connecting the postero-inferior point of the spinal cord at cranial and caudal vertebrae of the open-door segment in MRI, and simplify the mSC-line types into mSC-line(+) and mSC-line(-). In other words, mK-line and mSC-line in MRI are not fixed, but vary depending on the preoperative open-door segments. This study included patients with LAMP surgery for follow up, whose mK-line and mSC-line in MRI were double-positive for preoperative deciding open-door segments.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Jiangsu
      • Nantong, Jiangsu, China, 226000
        • Recruiting
        • The Second Affiliated Hospital of Nantong University
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The investigators intended to investigate the combined Impact of mK-line and mSC-line on the selection of the surgical approach and whether could be used to predict sufficient decompression of cervical spinal cord and clinical outcome in patients after LAMP.

Description

Inclusion Criteria:

(1) Diagnosis of MCSM confirmed by two spine surgeons with MRI examination and clinic signs; (2) More than 2 level lesions and/or spinal stenosis in MRI, underwent LAMP surgery; (3) Available for both preoperative and follow-up imaging data and clinical data, including sex, age, clinical symptoms, Japanese Orthopedic Association (JOA) score, Visual Analog Scale (VAS) score, Neck Disability Index(NDI) score and MRI data.

Exclusion Criteria:

(1) Previous cervical spine surgery; (2) Diagnosis of tumor, central cord syndrome, infection or other acute traumatic injuries; (3) Diagnosed neurological disorders Parkinson's disease, polio, multiple sclerosis, or other central and peripheral nervous system diseases).

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
MCSM
This study collected MRI images and baseline information of patients with multilevel cervical spondylotic myelopathy (MCSM) and underwent Laminoplasty (LAMP) surgery in Nantong First People's Hospital. No interventions would be used. This study just collect the MRI images pre- or postoperation to investigate the effect of the combination of mk-line and mSC-line on the selection of the surgical approach and whether could be used to predict sufficient decompression of cervical spinal cord and clinical outcome in patients after LAMP.
Diagnostic test: No Intervention: MCSM
No Intervention: MCSM

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
sex
Time Frame: From 2020 to 2026
male or female
From 2020 to 2026
age
Time Frame: From 2020 to 2026
years old, no month or date
From 2020 to 2026
Japanese Orthopedic Association (JOA) score
Time Frame: From 2020 to 2026
The Japanese Orthopaedic Association (JOA) score is widely used to assess the severity of clinical symptoms in patients with cervical compressive myelopathy. Scoring details refer to the Japanese orthopaedic association score (JOA-score modified by Keller 1993)
From 2020 to 2026
Neck Disability Index(NDI) score
Time Frame: From 2020 to 2026

The NDI can be scored as a raw score doubled and expressed as a percent. Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'. Points summed to a total score. The test can be interpreted as a raw score, with a maximum score of 50, or as a percentage.

0 points or 0% means : no activity limitations , 50 points or 100% means complete activity limitation.
From 2020 to 2026
Cobb angle
Time Frame: From 2020 to 2026
The Cobb angle is obtained by drawing parallel lines extending from the lower endplate of the most superior vertebral level (C2) and the lower endplate of the most inferior vertebral level (C7).
From 2020 to 2026
Ishihara's Cervical Curvature Index(CCI)
Time Frame: From 2020 to 2026
Ishihara's Cervical Curvature Index(CCI) = (a1 + a2 + a3 + a4)/L*100, where a1 - 4 are the distances between the posterior margins of the inferior endplates of vertebral bodies and a line between the posterior aspects of the inferior endplates of C2 and C7(distance defined as L).
From 2020 to 2026
Visual Analog Scale (VAS) score
Time Frame: From 2020 to 2026
A Visual Analogue Scale (VAS) is one of the pain rating scales used for the first time in 1921 by Hayes and Patterson.The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions. VAS can be presented in a way a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health) orientated from the left (worst) to the right (best). Patients points the scores and the investigators recorded.
From 2020 to 2026

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Affiliated 2 Hospital of Nantong University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Natural Science Foundation of China

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zhiming Cui, Professor, Second Affiliated Hospital of Nantong University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 27, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • mK-line and mSC-line

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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