NCT05867732

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2022

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 22, 2023

Completed
Last Updated

May 22, 2023

Status Verified

May 1, 2023

Enrollment Period

9 days

First QC Date

May 11, 2023

Last Update Submit

May 19, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Collect demographics (Hospital Information System)

    Collect demographics from the HIS system for patients with degenerative spine disease

    2022.03

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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;

You may not qualify if:

  • Patients with oncology;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wenle Li

Xianmencun, 361102, China

Location

Related Publications (2)

  • 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.

  • Li W, Zhang Y, Zhou X, Quan X, Chen B, Hou X, Xu Q, He W, Chen L, Liu X, Zhang Y, Xiang T, Li R, Liu Q, Wu SN, Wang K, Liu W, Zheng J, Luan H, Yu X, Chen A, Xu C, Luo T, Hu Z. Ensemble learning-assisted prediction of prolonged hospital length of stay after spine correction surgery: a multi-center cohort study. J Orthop Surg Res. 2024 Feb 2;19(1):112. doi: 10.1186/s13018-024-04576-4.

Study Officials

  • Wenle Wenle, M.D.

    Xiamen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

May 11, 2023

First Posted

May 22, 2023

Study Start

March 1, 2022

Primary Completion

March 10, 2022

Study Completion

March 1, 2023

Last Updated

May 22, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations