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Development and Validation of Interpretable Machine Learning Models Incorporating Paraspinal Muscle Quality for to Predict Cage Subsidence Risk Followingposterior Lumbar Interbody Fusion

Development and Validation of Interpretable Machine Learning Models Incorporating Paraspinal Muscle Quality for to Predict Cage Subsidence Risk Followingposterior Lumbar Interbody Fusion

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06888739
Enrollment
720
Registered
2025-03-21
Start date
2025-03-01
Completion date
2025-03-15
Last updated
2025-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cage, Degenerative Lumbar Diseases, Machine Learning

Keywords

Degenerative lumbar disease, Cage subsidence, Machine learning

Brief 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.

Interventions

PROCEDUREMR4

The study is a clinical retrospective study and does not involve any interventional measures.

Sponsors

Hao Liu
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

1. confirmed lumbar disc herniation, spinal stenosis, or spondylolisthesis based on clinical and imaging findings; 2. patients who failed conservative treatment for ≥3 months or experienced recurrence and underwent surgery for the first time; 3. minimum 12-month follow-up.

Exclusion criteria

1. prior spinal surgery; 2. spinal deformity or severe instability; 3. lumbar tuberculosis, infection, tumor, or severe bone destruction; 4. incomplete or lost follow-up.

Design outcomes

Primary

MeasureTime frameDescription
Bone density imaging indicator: Vertebral Bone Quality (VBQ)Preoperative measurement for PLIF (Posterior Lumbar Interbody Fusion)VBQ is calculated by dividing the mean T1 signal intensity (L1-L4) by the cerebrospinal fluid (CSF) signal at L3

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026