Effectiveness of T2* MRI in Cervical Spondylotic Myelopathy

NCT ID: NCT04955041

Last Updated: 2021-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2022-06-30

Brief Summary

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Utilization of T2\* MRI in predicting prognosis in patients with cervical spondylotic myelopathy (CSM)

Detailed Description

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Cervical spondylotic myelopathy (CSM), an age-related degenerative disease that is common worldwide, is mainly caused by compression of the spinal cord and may possibly lead to disability. Surgery to reduce direct compression of the spinal cord might alleviate disease progression; due to individual differences, some patients do not benefit from surgery. Prognostic prediction is important because it affects subsequent treatment decision making. Currently, prognosis is generally based on magnetic resonance imaging (MRI) with a detailed macrostructural evaluation of the spinal cord. Unfortunately, the use of conventional MRI indicators (e.g., increased intensity signal \[ISI\]) to predict CSM outcomes has been controversial because of their subjectivity or the insufficient information contained therein.

A new biomarker, T2\* MRI gray matter to white matter signal intensity ratio (GM/WM), is associated with demyelination and gliosis. Previous studies have shown that patients with CSM can have T2\* MRI WM / GM changes at the early stage of disease, and the WM / GM value is increased, which is significantly higher than that of normal people, and is related to the spinal cord function score. However, the correlation between this index and long-term prognosis remains to be studied.

Conditions

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Cervical Spondylotic Myelopathy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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mild CSM

preoperative modified Japanese Orthopedic Association (mJOA) score ≥15

MRI

Intervention Type OTHER

T2\* MRI

moderate CSM

preoperative mJOA score 13\~14

MRI

Intervention Type OTHER

T2\* MRI

severe CSM

preoperative mJOA score ≤12

MRI

Intervention Type OTHER

T2\* MRI

Interventions

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MRI

T2\* MRI

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* diagnosed with CSM and operated on by one senior orthopedist
* available preoperative MRI results
* high-quality image data with no motion artifacts
* available preoperative and long-term follow-up (≥1 years) mJOA score

Exclusion Criteria

* prior head or neck surgery
* a history of notable additional diseases (spinal cord tumor, multiple sclerosis, syringomyelia, spinal cord injury, or motor neuron disease).
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Huishu Yuan

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Other Identifiers

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M2020317

Identifier Type: -

Identifier Source: org_study_id

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