Dixon MRI Imaging Histology for Predicting Postoperative Infection in Posterior Lumbar Fusion for Myasthenia Gravis

January 28, 2025 updated by: Yijin Wang, The First People's Hospital of Yunnan
Sarcopenia is an age-related condition that manifests itself as a persistent decrease in muscle mass and function, which may lead to decreased physical function, increased risk of disease, and reduced quality of life. In surgical patients, sarcopenia has been shown to be associated with increased postoperative complications, prolonged hospitalization, and decreased survival. In patients undergoing lumbar fusion, the presence of sarcopenia may increase the risk of postoperative infection.Lumbar fusion is a common procedure to treat lumbar spine disorders such as lumbar disc herniation, lumbar spondylolisthesis, or lumbar spinal stenosis. However, this procedure is associated with a high rate of complications, especially postoperative infections, which can lead to reoperation, prolonged hospitalization, and even affect patient survival. In recent years, more and more studies have found a significant association between sarcopenia and postoperative infections after lumbar fusion surgery.Imagingomics belongs to a branch of machine learning, which is the process of acquiring images from various imaging devices such as CT, MRI and ultrasound, outlining the region of interest through image segmentation, extracting the features of the image within the region of interest, downscaling the features, and finally building an imagingomics model. MRI Imagingomics, utilizing its rich data information, has shown great potential for application in several medical fields. Among them, the accuracy of Dixon MRI imaging histology in muscle mass and texture assessment makes it particularly important in predicting postoperative infections.Based on this, it is reasonable to believe that Dixon MRI imaging histology can be a powerful tool to help us predict a patient's risk of postoperative infection.

Study Overview

Status

Not yet recruiting

Study Type

Observational

Enrollment (Estimated)

1300

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

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Retrospective multicenter collection of infected/non-infected myasthenia gravis and non-myasthenia gravis patients after posterior lumbar fusion at our institution and at each of the collaborating research institutions.

Description

Inclusion Criteria:

  • Male and female patients over 18 years of age.
  • Inclusion of patients with sarcopenia is subject to the definition and diagnostic criteria of the European Consensus on Definition and Diagnosis of Sarcopenia.
  • The patient underwent posterior lumbar fusion and had a Dixon MRI scan within 2 weeks prior to surgery.
  • Patients were able to understand the purpose and procedures of the study and were willing to sign an informed consent form.
  • The patient's clinical consultation and follow-up information was complete.

Exclusion Criteria:

  • The patient has contraindications to MRI, such as implanted metal devices (e.g., pacemakers) or severe claustrophobia.
  • Patients with serious other medical conditions, such as heart disease, kidney disease or liver disease, which may affect their post-operative recovery.
  • Patients have known immune system disorders or are on immunosuppressive therapy, which may affect their risk of infection.
  • The patient has had other spinal surgery within the last 6 months.

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
postoperative infection
Non-operative infections

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
fat fraction
Time Frame: Two weeks before treatment
Two weeks before treatment

Collaborators and Investigators

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

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 (Estimated)

February 1, 2025

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

February 28, 2026

Study Registration Dates

First Submitted

January 28, 2025

First Submitted That Met QC Criteria

January 28, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 28, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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