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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05170321
Other study ID # 2017121016
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date December 1, 2022

Study information

Verified date November 2021
Source Xiangya Hospital of Central South University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 600000
Est. completion date December 1, 2022
Est. primary completion date December 1, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Locations

Country Name City State
China Xiangya Hospital of Central South University Changsha Hunan

Sponsors (1)

Lead Sponsor Collaborator
Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

References & Publications (1)

Zeng C, Lane NE, Englund M, Xie D, Chen H, Zhang Y, Wang H, Lei G. In-hospital mortality after hip arthroplasty in China: analysis of a large national database. Bone Joint J. 2019 Oct;101-B(10):1209-1217. doi: 10.1302/0301-620X.101B10.BJJ-2018-1608.R1. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Epidemiological characteristics, complications, risk factors and resource utilization of knee arthroplasty in China 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)
Primary Epidemiological characteristics, complications, risk factors and resource utilization of hip arthroplasty in China 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)
Primary Epidemiological characteristics, complications, risk factors and resource utilization of shoulder arthroplasty in China 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)
Primary Epidemiological characteristics, complications, risk factors and resource utilization of ankle arthroplasty in China 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)
Primary Epidemiological characteristics, complications, risk factors and resource utilization of elbow arthroplasty in China 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)
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