- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05170321
Analysis of Influencing Factors and Construction of Prediction Models of Artificial Joint Replacement in China
30. december 2021 opdateret af: 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.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Undersøgelsestype
Observationel
Tilmelding (Forventet)
600000
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Hunan
-
Changsha, Hunan, Kina, 410008
- Xiangya Hospital of Central South University
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients who underwent knee, hip, shoulder, ankle and elbow arthroplasty were included.
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
---|
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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Epidemiological characteristics, complications, risk factors and resource utilization of knee arthroplasty in China
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Guanghua Lei, PhD; MD, Xiangya Hospital
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. januar 2018
Primær færdiggørelse (Forventet)
1. december 2022
Studieafslutning (Forventet)
1. december 2022
Datoer for studieregistrering
Først indsendt
8. december 2021
Først indsendt, der opfyldte QC-kriterier
8. december 2021
Først opslået (Faktiske)
27. december 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
14. januar 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. december 2021
Sidst verificeret
1. november 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2017121016
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
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.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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