NCT05170321

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

December 8, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 27, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

January 14, 2022

Status Verified

November 1, 2021

Enrollment Period

4.9 years

First QC Date

December 8, 2021

Last Update Submit

December 30, 2021

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

Study Arms (5)

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent knee, hip, shoulder, ankle and elbow arthroplasty were included.

You may qualify if:

  • Patients who underwent knee, hip, shoulder, ankle and elbow arthroplasty in HQMS

You may not qualify if:

  • Patients who didn't undergo knee, hip, shoulder, ankle and elbow arthroplasty
  • Patients with missing demographics or medical data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

Location

Related Publications (3)

  • 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.

    PMID: 31564156BACKGROUND
  • Wang Y, Jiang Q, Long H, Chen H, Wei J, Li X, Wang H, Xie D, Zeng C, Lei G. Trends and benefits of early hip arthroplasty for femoral neck fracture in China: a national cohort study. Int J Surg. 2024 Mar 1;110(3):1347-1355. doi: 10.1097/JS9.0000000000000794.

  • Long H, Xie D, Chen H, Wei J, Li X, Wang H, Zeng C, Lei G. Rural-urban differences in characteristics, postoperative outcomes, and costs for patients undergoing knee arthroplasty: a national retrospective propensity score matched cohort study. Int J Surg. 2023 Sep 1;109(9):2696-2703. doi: 10.1097/JS9.0000000000000494.

Study Officials

  • Guanghua Lei, PhD; MD

    Xiangya Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2021

First Posted

December 27, 2021

Study Start

January 1, 2018

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

January 14, 2022

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

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.

Locations