Multivariate Analysis and Machine Learning Model Risk Pre... | NCT06622356

ID	Type	Description	Link
(2024) Lun Yan Grant No. 517	Other Identifier	Medical Ethics Committee of the First Affiliated Hospital of Soochow University

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 20, 2024Actual

Primary Completion Date

Sep 25, 2024Actual

Completion Date

Sep 28, 2024Actual

First Submitted Date

Sep 28, 2024

First Submission Date that Met QC Criteria

Oct 1, 2024

First Posted Date

Oct 2, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 1, 2024

Last Update Posted Date

Oct 2, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

452Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rehabilitation Group		Rehabilitation Group (n = 268): mild/non pain group with VAS<3 at 12-18 months after PLIF。The study was retrospective and did not design an intervention	Other: MRI with Eovist
Recurrent pain group		Recurrent pain group (n = 184): recurrent pain group with VAS≥3 at 12-18 months after PLIF	Other: MRI with Eovist

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MRI with Eovist	Other	The study was retrospective and did not design an intervention	Recurrent pain group Rehabilitation Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
SAS（Pain rating scale）	The visual analogue scale (VAS) was employed to determine the patient's perception of lower back pain or lower limb pain prior to surgery, as well as 12-18 months after surgery. (0-10 scale, with 0 being painless and 10 being the most painful)	12-18 months after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

confirmed diagnosis of lumbar degenerative disease (spinal stenosis, disc herniation with lumbar instability, and lumbar spondylolisthesis), with no significant symptomatic relief after conservative treatment for more than 3 months, and in need of surgical intervention;
lumbar spinal fusion surgical treatment with PLIF;
grouping based on the presence or absence of a lumbar or limb pain with VAS ≥3 at the 12-18 month postoperative follow-up;
observational indicators including individual factors, surgical factors, spine-pelvis sagittal balance parameters, and paravertebral muscle parameters.

Exclusion Criteria:

(1) those with a history of lumbar spine trauma, inflammation, tumor, or surgery; (2) those with congenital or acquired severe lumbar vertebral deformity; (3) those with severe neurological dysfunction; (4) those with incomplete baseline and follow-up data.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

This study retrospectively reviewed 452 patients suffering from degenerative lumbar spinedisorders in our institute between January 2019 and February 2023. The patients were separated into Recurrent pain group and Rehabilitation Group. Recurrent pain group (n = 268): mild/non pain group with VAS<3 at 12-18 months after PLIF；Rehabilitation Group (n = 184): recurrent pain group with VAS≥3 at 12-18 months after PLIF.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Medical record system and imaging system of the First Affiliated Hospital of Suzhou University		Suzhou	Jiangsu	215006	China

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Before January 1,2025;in the form of paper.The original data of the trial will be uploaded to Genome Sequence Archive (GSA) (ngdc.cncb.ac.cn)

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D007405	Intervertebral Disc Displacement
D055948	Sarcopenia

ID	Term
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms
D009133	Muscular Atrophy
D020879	Neuromuscular Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D001284	Atrophy
D012816	Signs and Symptoms

ID	Term
D009682	Magnetic Resonance Spectroscopy
C073590	gadolinium ethoxybenzyl DTPA

ID	Term
D013057	Spectrum Analysis
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques