- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06805643
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
Conditions
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
- Name: Zhisong Liang doc
- Phone Number: 0871-63648772
- Email: 771611474@qq.com
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
Additional Relevant MeSH Terms
- Nervous System Diseases
- Postoperative Complications
- Pathologic Processes
- Neoplasms by Site
- Neoplasms
- Neuromuscular Diseases
- Disease Attributes
- Autoimmune Diseases
- Immune System Diseases
- Autoimmune Diseases of the Nervous System
- Neurodegenerative Diseases
- Paraneoplastic Syndromes, Nervous System
- Nervous System Neoplasms
- Paraneoplastic Syndromes
- Neuromuscular Junction Diseases
- Wound Infection
- Infections
- Communicable Diseases
- Myasthenia Gravis
- Surgical Wound Infection
Other Study ID Numbers
- KHLL2023-KY209-GZ2024-12-23
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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