NCT04955041

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
10.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 8, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

July 8, 2021

Status Verified

July 1, 2020

Enrollment Period

10.5 years

First QC Date

June 29, 2021

Last Update Submit

June 29, 2021

Conditions

Cervical Spondylotic Myelopathy

Outcome Measures

Primary Outcomes (1)

  • Improvement of neurologic function

    Postoperative modified Japanese Orthopaedic Association (mJOA) at follow-up time

    at follow-up time (≥1 years)

Study Arms (3)

mild CSM

preoperative modified Japanese Orthopedic Association (mJOA) score ≥15

Other: MRI

moderate CSM

preoperative mJOA score 13\~14

Other: MRI

severe CSM

preoperative mJOA score ≤12

Other: MRI

Interventions

MRIOTHER

T2\* MRI

mild CSMmoderate CSMsevere CSM

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients came from Peking University Third Hospital

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Huishu Yuan

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2021

First Posted

July 8, 2021

Study Start

January 1, 2010

Primary Completion

July 1, 2020

Study Completion

June 1, 2022

Last Updated

July 8, 2021

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

No.