The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05867732
Recruitment Status : Completed
First Posted : May 22, 2023
Last Update Posted : May 22, 2023
Sponsor:
Information provided by (Responsible Party):
Wenle Li, Xiamen University

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Condition or disease
Degenerative Spine Diseases

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 1 Year
Official Title: A Multicenter Observational Cohort of Degenerative Spine Diseases in China
Actual Study Start Date : March 1, 2022
Actual Primary Completion Date : March 10, 2022
Actual Study Completion Date : March 1, 2023
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Collect demographics (Hospital Information System) [ Time Frame: 2022.03 ]
    Collect demographics from the HIS system for patients with degenerative spine disease


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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
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;
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05867732


Locations
Layout table for location information
China
Wenle Li
Xianmen, China, 361102
Sponsors and Collaborators
Xiamen University
Investigators
Layout table for investigator information
Principal Investigator: Wenle Wenle, M.D. Xiamen University
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Wenle Li, Dr., Xiamen University
ClinicalTrials.gov Identifier: NCT05867732    
Other Study ID Numbers: XiamenUDSDC
First Posted: May 22, 2023    Key Record Dates
Last Update Posted: May 22, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases