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

NCT ID: NCT06888739

Last Updated: 2025-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

720 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-01

Study Completion Date

2025-03-15

Brief Summary

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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.

Detailed Description

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Conditions

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Degenerative Lumbar Diseases Cage Machine Learning

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

MR4

Intervention Type PROCEDURE

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

Subsidence Group

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

MR4

Intervention Type PROCEDURE

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

Interventions

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MR4

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hao Liu

OTHER

Sponsor Role lead

Responsible Party

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Hao Liu

Department of Orthopedics, The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu Province, China

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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The First Affiliated Hospital of Soochow University Medical Record and Imaging System

Jiangsu, SuZhou, China

Site Status

Countries

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China

Other Identifiers

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(2025)Lun Yan Grant No. 220

Identifier Type: OTHER

Identifier Source: secondary_id

(2025)Lun Yan Grant No. 220

Identifier Type: -

Identifier Source: org_study_id

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