A Multicenter Observational Cohort of Degenerative Spine... | NCT05867732

Studies
A Multicenter Observational Cohort of Degenerative Spine Diseases in China（DSDC）

NCT05867732

Sponsor

Xiamen University

Status

Completed

Last Update Posted

May 22, 2023Actual

Enrollment

10,000Actual

Phase

Not provided

Conditions

Degenerative Spine Diseases

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

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

Mar 1, 2022Actual

Primary Completion Date

Mar 10, 2022Actual

Completion Date

Mar 1, 2023Actual

First Submitted Date

May 11, 2023

First Submission Date that Met QC Criteria

May 19, 2023

First Posted Date

May 22, 2023Actual

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

May 19, 2023

Last Update Posted Date

May 22, 2023Actual

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Study type: The objectives of this observational study were to understand, analyze, and compare the treatment and prognosis of patients with degenerative spine diseases and to construct a risk warning model and an assisted decision-making system

The main questions it aims to answer are:

[question 1] to construct a database of patients with degenerative spinal diseases and to study their associated prognosis, complications, and other risks
[Question 2] Use big data to build a risk early warning model and assisted decision making system The study will not intervene with patients

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10,000Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Collect demographics (Hospital Information System)	Collect demographics from the HIS system for patients with degenerative spine disease	2022.03

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

patients with degenerative spine disease admitted to the units participating in the study from January 2015 to mid-January 2022;
complete patient data with no more than 5% missing;

Exclusion Criteria:

Patients with oncology;

Accepts Healthy Volunteers

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

Patients with degenerative spine disease (lumbar disc herniation, lumbar spinal stenosis, lumbar spondylolisthesis, scoliosis deformity, etc.) seen and treated in participating units between January 2015 and January 2022, excluding patients with neoplastic disease

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wenle Wenle, M.D.	Xiamen University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wenle Li		Xianmencun		361102	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40540437	Derived	Shen N, Zhang Y, Ding Z, Li R, Quan X, Liu X, Zhang Y, Xiang T, Zhang Y, Yin C, Li W. Predicting intraoperative blood loss risk in severe lumbar disc herniation patients undergoing PLIF: a multicenter cohort study using ensemble learning. Int J Surg. 2025 Sep 1;111(9):5904-5913. doi: 10.1097/JS9.0000000000002730. Epub 2025 Jun 19.
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