Lumbar VertebraeNCT06805643
Dixon MRI Imaging Histology for Predicting Postoperative Infection in Posterior Lumbar Fusion for Myasthenia Gravis
An observational study of Lumbar Vertebrae and Surgical Site Infection, run by The First People's Hospital of Yunnan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Vertebrae, Surgical Site Infection, Radiomics
- How many people
- 1,300 participants
- Where
- No sites listed yet
- Study dates
- Feb 2025to 28 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Lumbar Vertebrae, Surgical Site Infection, Radiomics
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| postoperative infection | Not described | |
| Non-operative infections | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
fat fraction
Measured: Two weeks before treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study startFeb 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar VertebraeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First People's Hospital of Yunnan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yijin Wang, The First People's Hospital of Yunnan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06805643
- Sponsor's protocol ID
- KHLL2023-KY209-GZ2024-12-23
- Status last verified
- Jan 2025
- First submitted
- 28 Jan 2025
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dixon MRI Imaging Histology for Predicting Postoperative Infection in Posterior Lumbar Fusion for Myasthenia Gravis
- ClinicalTrials.gov ID
- NCT06805643
- Acronym / sponsor ID
- KHLL2023-KY209-GZ2024-12-23
- Conditions
- Lumbar Vertebrae, Surgical Site Infection, Radiomics
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- The First People's Hospital of YunnanUniversity, hospital or other
- Study start
- Feb 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 3 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| postoperative infection | – | – |
| Non-operative infections | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
fat fraction
Time frame: Two weeks before treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Vertebrae and Surgical Site Infection, run by The First People's Hospital of Yunnan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhisong Liang doc (0871-63648772, 771611474@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fat fraction (time frame: Two weeks before treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.