Clinical trial NCT05170321: Analysis of Influencing Factors and Construction of Prediction Models of Artificial Joint Replacement in China
Official title: Analysis of Influencing Factors and Construction of Prediction Models of Artificial Joint Replacement in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Knee Arthropathy
Hip Arthropathy
Shoulder Arthropathy
Ankle Arthropathy
Elbow Arthropathy
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2021-12-27
Enrollment: 600000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent knee, hip, shoulder, ankle and elbow arthroplasty were included.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Epidemiological characteristics, complications, risk factors and resource utilization of knee arthroplasty in China
timeFrame: 10 years (2013-2022)
measure: Epidemiological characteristics, complications, risk factors and resource utilization of hip arthroplasty in China
timeFrame: 10 years (2013-2022)
measure: Epidemiological characteristics, complications, risk factors and resource utilization of shoulder arthroplasty in China
timeFrame: 10 years (2013-2022)
measure: Epidemiological characteristics, complications, risk factors and resource utilization of ankle arthroplasty in China
timeFrame: 10 years (2013-2022)
measure: Epidemiological characteristics, complications, risk factors and resource utilization of elbow arthroplasty in China
timeFrame: 10 years (2013-2022)
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
Study officials:
affiliation: Xiangya Hospital
name: Guanghua Lei, PhD; MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.