Development and Validation of Interpretable Machine Learning Models Incorporating Paraspinal Musc… (NCT06888739) | Clinical Trial Compass
CompletedNot Applicable
Development and Validation of Interpretable Machine Learning Models Incorporating Paraspinal Muscle Quality for to Predict Cage Subsidence Risk Followingposterior Lumbar Interbody Fusion
China720 participantsStarted 2025-03-01
Plain-language summary
The study focuses on identifying risk factors for cage subsidence after posterior lumbar interbody fusion (PLIF) and developing an interpretable machine learning model to predict these risks. It analyzes patients from two large teaching hospitals, using clinical, radiographic, and surgical parameters, including paraspinal muscle indices and bone density markers. A web-based application was developed to facilitate real-time clinical risk assessments using the machine learning model, enhancing surgical planning and reducing subsidence risks.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. confirmed lumbar disc herniation, spinal stenosis, or spondylolisthesis based on clinical and imaging findings;
. patients who failed conservative treatment for ≥3 months or experienced recurrence and underwent surgery for the first time;
. minimum 12-month follow-up.
Exclusion criteria
. prior spinal surgery;
. spinal deformity or severe instability;
. lumbar tuberculosis, infection, tumor, or severe bone destruction;
. incomplete or lost follow-up.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Bone density imaging indicator: Vertebral Bone Quality (VBQ)
Timeframe: Preoperative measurement for PLIF (Posterior Lumbar Interbody Fusion)