Degenerative Lumbar DiseasesNCT06888739
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 of Degenerative Lumbar Diseases and Cage, run by Hao Liu at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Degenerative Lumbar Diseases, Cage, Machine Learning
- What is being tested?
- MR4
- Type of treatment
- Surgery or procedure
- How many people
- 720 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 15 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- prior spinal surgery;
- spinal deformity or severe instability;
- lumbar tuberculosis, infection, tumor, or severe bone destruction;
- incomplete or lost follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Soochow University Medical Record and Imaging System
Jiangsu, SuZhou, 215006
About this study
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.
- Conditions
- Degenerative Lumbar Diseases, Cage, Machine Learning
- Being tested
- MR4
- Keywords
- Degenerative lumbar disease, Cage subsidence, Machine learning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR4Procedure or surgery
The study is a clinical retrospective study and does not involve any interventional measures.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: MR4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Preoperative measurement for PLIF (Posterior Lumbar Interbody Fusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start1 Mar 2025
- Primary completion10 Mar 2025
- Study completion15 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Lumbar DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 720 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hao Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hao Liu, First Affiliated Hospital of Suzhou Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888739
- Sponsor's protocol ID
- （2025）Lun Yan Grant No. 220
- Other IDs
- （2025）Lun Yan Grant No. 220
- Status last verified
- Mar 2025
- First submitted
- 17 Mar 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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)
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of Interpretable Machine Learning Models Incorporating Paraspinal Muscle Quality for to Predict Cage Subsidence Risk Followingposterior Lumbar Interbody Fusion
- ClinicalTrials.gov ID
- NCT06888739
- Acronym / sponsor ID
- （2025）Lun Yan Grant No. 220
- Conditions
- Degenerative Lumbar Diseases, Cage, Machine Learning
- Keywords
- Degenerative lumbar disease, Cage subsidence, Machine learning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 720 participants (actual)
- Lead sponsor
- Hao LiuUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 10 Mar 2025 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Subsidence Group | – | Procedure: MR4Group A (n = 390): Lost IH value <2 mm.Cage subsidence was defined as a lost IH value ≥2 mm during the follow-up period |
| Subsidence Group | – | Procedure: MR4Lost IH value ≥2 mm.Cage subsidence was defined as a lost IH value ≥2 mm during the follow-up period |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- prior spinal surgery;
- spinal deformity or severe instability;
- lumbar tuberculosis, infection, tumor, or severe bone destruction;
- incomplete or lost follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MR4The study is a clinical retrospective study and does not involve any interventional measures. | Procedure or surgery | Non-Subsidence Group, Subsidence Group |
Primary outcome
Bone density imaging indicator: Vertebral Bone Quality (VBQ)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Individual participant dataSharing planned: 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)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Lumbar Diseases and Cage, run by Hao Liu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone density imaging indicator: Vertebral Bone Quality (VBQ) (time frame: Preoperative measurement for PLIF (Posterior Lumbar Interbody Fusion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.