CClinicalTrials.gg
CompletedNCT06888739Updated Mar 21, 2025

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

An observational study in Degenerative Lumbar Diseases, Cage and Machine Learning, sponsored by Hao Liu. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2025-03-21.

Sponsored by Hao Liu · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
720
Sex
All
01

Study 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.

02

Conditions studied

  • Degenerative Lumbar Diseases
  • Cage
  • Machine Learning

Keywords

  • Degenerative lumbar disease
  • Cage subsidence
  • Machine learning
03

In context

Lead sponsor

Hao Liu is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

This retrospective study included patients with degenerative lumbar diseases who underwent single-level PLIF at the First and Second Affiliated Hospitals of Soochow University (January 2018-October 2023).A total of 620 patients from the First Affiliated Hospital comprised the training set, while 100 patients from the Second Affiliated Hospital formed the external validation set. The study adhered to the Declaration of Helsinki and was approved by the institutional ethics committee.

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

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.
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
720 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Non-Subsidence Group

    Group A (n = 390): Lost IH value \<2 mm.Cage subsidence was defined as a lost IH value ≥2 mm during the follow-up period

    Procedure: MR4

  • Subsidence Group

    Lost IH value ≥2 mm.Cage subsidence was defined as a lost IH value ≥2 mm during the follow-up period

    Procedure: MR4

Interventions

  • ProcedureMR4

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

06

What researchers measure

Primary outcomes

  1. Bone density imaging indicator: Vertebral Bone Quality (VBQ)

    VBQ is calculated by dividing the mean T1 signal intensity (L1-L4) by the cerebrospinal fluid (CSF) signal at L3

    Time frame: Preoperative measurement for PLIF (Posterior Lumbar Interbody Fusion)

07

Study locations

1 site
  • The First Affiliated Hospital of Soochow University Medical Record and Imaging System
    Jiangsu, SuZhou 215006, China
08

References and documents

Individual participant data

Plan to share: Yes — Before January 1,2026;in the form of paper. The original data of the trial will be uploaded to Genome Sequence Archive (GSA) (ngdc.cncb.ac.cn)

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06888739
Lead sponsor
Hao Liu
Responsible party
Hao Liu (Department of Orthopedics, The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu Province, China, First Affiliated Hospital of Suzhou Medical College) — Sponsor-investigator
First posted
Mar 21, 2025
Start date
Mar 1, 2025
Primary completion
Mar 10, 2025
Completion
Mar 15, 2025
Last update
Mar 21, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion