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NCT06064318 Clinical Trial

Prevalence and Incidence of Multiple Revisions Following Knee Arthroplasty in Denmark 1998-2021: A Nationwide Population-based Study

Knee Replacement Clinical Trial

— EMKAR ONE  

Official title:
Prevalence and Incidence of Multiple Revisions Following Knee Arthroplasty in Denmark 1998-2021: A Nationwide Population-based Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06064318
Other study ID # 08062023
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2023
Est. completion date April 1, 2024

Study information
Verified date April 2024
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to investigate the incidence and prevalence rates of multiply revised knee arthroplasty patients in Denmark from 1998-2021.

Recruitment information / eligibility
Status Completed
Enrollment 161384
Est. completion date April 1, 2024
Est. primary completion date September 2, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - Danish Resident - between 18-99 years of age - must have had primary knee arthroplasty procedure performed in Denmark between 1998-2021 Exclusion Criteria: - Missing key variables (patient ID, date of surgery, procedure-code, laterality of procedure) - Duplicates - Non-relevant procedures

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Revision
Any type of knee revision, excluding knee arthrodesis and femur amputation

Locations
Country Name City State
Denmark Rigshospitalet Copenhagen

Sponsors (3)
Lead Sponsor Collaborator
Rigshospitalet, Denmark Bispebjerg Hospital, Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence of major n-grade revisions standardized prevalence of major n-grade revisions 23 years
Primary Incidence of major n-grade revisions standardized incidence of major n-grade revisions 23 years
Primary Prevalence of all n-grade revisions standardized prevalence of all n-grade revisions 23 years
Primary Incidence of all n-grade revisions standardized incidence of all n-grade revisions 23 years
Secondary Incidence of major and all n-grade revisions stratified by sex and age Calculation of incidence for major and for all n-grade revisions stratified by sex and by age (groups, sex: male/female, age: 18-49/50-69/70-99) 23 years
Secondary Prevalence of major and all n-grade revisions stratified by sex and age Calculation of prevalence for major and for all n-grade revisions stratified by sex and by age (groups, sex: male/female, age: 18-49/50-69/70-99) 23 years
Secondary Prevalence of major and all n-grade revisions for patients with their total sum of revisions Calculation of standardized prevalence for patients receiving major or all type of n-grade revision, where the ordering of revisions are not knee specific but patient-specific 23 Years
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