- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05170321
Analysis of Influencing Factors and Construction of Prediction Models of Artificial Joint Replacement in China
December 30, 2021 updated by: Xiangya Hospital of Central South University
The project intends to analyze the epidemiological characteristics, risk factors, complications and resource utilization of artificial joint replacement in China through the inpatient data collected by the Hospital Quality Monitoring System (HQMS).
The HQMS database is a mandatory electronic inpatient database system developed by the National Health Commission of the People's Republic of China.
Since 2013, tertiary hospitals have been required to upload their inpatient discharge records.
By 2019, the HQMS database has included more than 230 million standardized inpatient discharge records of over 1000 hospitals across all 31 provincial-level administrative regions in mainland China.
Patient demographics, clinical diagnosis, procedures and operations, drug use, costs and complications were all recorded in the HQMS database.
The investigators planned to include five types of arthroplasty, including knee arthroplasty, hip arthroplasty, shoulder arthroplasty, ankle arthroplasty and elbow arthroplasty.
The data analysis will be conformed to the principle of confidentiality and will not reveal the privacy of those patients.
The data will be only used for this research project and there is no conflict of interest.
It is in line with the principles of ethics, harmlessness and fairness.
This study was authorized by the HQMS Committee Board and approved by the institutional review board, with waiver of informed consent.
Study Overview
Status
Active, not recruiting
Study Type
Observational
Enrollment (Anticipated)
600000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Hunan
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Changsha, Hunan, China, 410008
- Xiangya Hospital of Central South University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who underwent knee, hip, shoulder, ankle and elbow arthroplasty were included.
Description
Inclusion Criteria:
- Patients who underwent knee, hip, shoulder, ankle and elbow arthroplasty in HQMS
Exclusion Criteria:
- Patients who didn't undergo knee, hip, shoulder, ankle and elbow arthroplasty
- Patients with missing demographics or medical data
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
patients undergoing knee arthroplasty in Hospital Quality Monitoring System in China
Patients who underwent knee arthroplasty and was recorded in HQMS were included in this group
|
patients undergoing hip arthroplasty in Hospital Quality Monitoring System in China
Patients who underwent hip arthroplasty and was recorded in HQMS were included in this group
|
patients undergoing shoulder arthroplasty in Hospital Quality Monitoring System in China
Patients who underwent shoulder arthroplasty and was recorded in HQMS were included in this group
|
patients undergoing ankle arthroplasty in Hospital Quality Monitoring System in China
Patients who underwent ankle arthroplasty and was recorded in HQMS were included in this group
|
patients undergoing elbow arthroplasty in Hospital Quality Monitoring System in China
Patients who underwent elbow arthroplasty and was recorded in HQMS were included in this group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Epidemiological characteristics, complications, risk factors and resource utilization of knee arthroplasty in China
Time Frame: 10 years (2013-2022)
|
The project intends to analyze the epidemiological characteristics, complications, risk factors and resource utilization of artificial knee joint replacement in China through the inpatient data collected by the Hospital Quality Monitoring System (HQMS).
The information collected by HQMS includes demographics characteristics, hospitalization information, medical care cost, complications, et al.
|
10 years (2013-2022)
|
Epidemiological characteristics, complications, risk factors and resource utilization of hip arthroplasty in China
Time Frame: 10 years (2013-2022)
|
The project intends to analyze the epidemiological characteristics, complications, risk factors and resource utilization of artificial hip joint replacement in China through the inpatient data collected by the Hospital Quality Monitoring System (HQMS).
The information collected by HQMS includes demographics characteristics, hospitalization information, medical care cost, complications, et al.
|
10 years (2013-2022)
|
Epidemiological characteristics, complications, risk factors and resource utilization of shoulder arthroplasty in China
Time Frame: 10 years (2013-2022)
|
The project intends to analyze the epidemiological characteristics, complications, risk factors and resource utilization of artificial shoulder joint replacement in China through the inpatient data collected by the Hospital Quality Monitoring System (HQMS).
The information collected by HQMS includes demographics characteristics, hospitalization information, medical care cost, complications, et al.
|
10 years (2013-2022)
|
Epidemiological characteristics, complications, risk factors and resource utilization of ankle arthroplasty in China
Time Frame: 10 years (2013-2022)
|
The project intends to analyze the epidemiological characteristics, complications, risk factors and resource utilization of artificial ankle joint replacement in China through the inpatient data collected by the Hospital Quality Monitoring System (HQMS).
The information collected by HQMS includes demographics characteristics, hospitalization information, medical care cost, complications, et al.
|
10 years (2013-2022)
|
Epidemiological characteristics, complications, risk factors and resource utilization of elbow arthroplasty in China
Time Frame: 10 years (2013-2022)
|
The project intends to analyze the epidemiological characteristics, complications, risk factors and resource utilization of artificial elbow joint replacement in China through the inpatient data collected by the Hospital Quality Monitoring System (HQMS).
The information collected by HQMS includes demographics characteristics, hospitalization information, medical care cost, complications, et al.
|
10 years (2013-2022)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Guanghua Lei, PhD; MD, Xiangya Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2018
Primary Completion (Anticipated)
December 1, 2022
Study Completion (Anticipated)
December 1, 2022
Study Registration Dates
First Submitted
December 8, 2021
First Submitted That Met QC Criteria
December 8, 2021
First Posted (Actual)
December 27, 2021
Study Record Updates
Last Update Posted (Actual)
January 14, 2022
Last Update Submitted That Met QC Criteria
December 30, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017121016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The investigators do not wish to share our data according to the policy of our hospital, the data could not be shared with others without permission.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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