NCT06805643

Brief 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. 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.

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
1,300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2025

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

January 28, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

February 3, 2025

Status Verified

January 1, 2025

Enrollment Period

11 months

First QC Date

January 28, 2025

Last Update Submit

January 28, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • fat fraction

    Two weeks before treatment

Study Arms (2)

postoperative infection

Non-operative infections

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Male and female patients over 18 years of age.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Zhisong Liang doc

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doc

Study Record Dates

First Submitted

January 28, 2025

First Posted

February 3, 2025

Study Start

February 1, 2025

Primary Completion

December 31, 2025

Study Completion

February 28, 2026

Last Updated

February 3, 2025

Record last verified: 2025-01