Degenerative Spine DiseasesDSDCNCT05867732
A Multicenter Observational Cohort of Degenerative Spine Diseases in China（DSDC）
An observational study of Degenerative Spine Diseases, run by Xiamen University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Degenerative Spine Diseases
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 1 Mar 2023
- How long will I take part?
- 1 Year
- 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
- No healthy volunteers
- Child, Adult, Older 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
Who may be able to join
- 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;
Who cannot join
- Patients with oncology;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter Observational Cohort of Degenerative Spine Diseases in China
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
- Conditions
- Degenerative Spine Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Collect demographics (Hospital Information System)
Collect demographics from the HIS system for patients with degenerative spine disease
Measured: 2022.03
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start1 Mar 2022
- Primary completion10 Mar 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Degenerative Spine 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
- Cohort
- Time perspective
- Other
- Enrolment
- 10,000 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Xiamen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenle Li, Xiamen University
- Investigators
- Wenle Wenle, M.D., Principal investigator, Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05867732
- Sponsor's protocol ID
- XiamenUDSDC
- Acronym
- DSDC
- Status last verified
- May 2023
- First submitted
- 11 May 2023
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40540437Li 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.
PubMed 38308336
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Observational Cohort of Degenerative Spine Diseases in China
- ClinicalTrials.gov ID
- NCT05867732
- Acronym / sponsor ID
- DSDC / XiamenUDSDC
- Conditions
- Degenerative Spine Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,000 participants (actual)
- Lead sponsor
- Xiamen UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 10 Mar 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 22 May 2023 (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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older 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
Key inclusion criteria (2 listed)
- 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;
Key exclusion criteria (1 listed)
- Patients with oncology;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Collect demographics (Hospital Information System)
Time frame: 2022.03
Collect demographics from the HIS system for patients with degenerative spine disease
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 22 May 2023.
- Derived from this study: PubMed 40540437Shen 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.
- Derived from this study: PubMed 38308336Li 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.
- Individual participant dataSharing planned: No
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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.
Wenle Wenle, M.D. principal investigator
Xiamen University
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 Spine Diseases, run by Xiamen University 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 2 inclusion and 1 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 22 May 2023. 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?
Collect demographics (Hospital Information System) (time frame: 2022.03). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05867732, which also lists 2 linked publications.
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 22 May 2023.