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

April 9, 2024 updated by: Julius Tetens Hald, Rigshospitalet, Denmark
The purpose of this study is to investigate the incidence and prevalence rates of multiply revised knee arthroplasty patients in Denmark from 1998-2021.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

161384

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

All Danish residents between the ages of 18-99 who received a primary knee arthroplasty in Denmark between 1998-2021.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Primary cohort
All patients with a primary knee arthroplasty performed in Denmark between Jan 1st 1998 and 31st December 2021.
Revision cohort
All patients with a revision knee arthroplasty performed in Denmark between Jan 1st 1998 and 31st December 2021
Procedure: Revision
Any type of knee revision, excluding knee arthrodesis and femur amputation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of major n-grade revisions
Time Frame: 23 years
standardized prevalence of major n-grade revisions
23 years
Incidence of major n-grade revisions
Time Frame: 23 years
standardized incidence of major n-grade revisions
23 years
Prevalence of all n-grade revisions
Time Frame: 23 years
standardized prevalence of all n-grade revisions
23 years
Incidence of all n-grade revisions
Time Frame: 23 years
standardized incidence of all n-grade revisions
23 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of major and all n-grade revisions stratified by sex and age
Time Frame: 23 years
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
Prevalence of major and all n-grade revisions stratified by sex and age
Time Frame: 23 years
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
Prevalence of major and all n-grade revisions for patients with their total sum of revisions
Time Frame: 23 Years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

Odense University Hospital
Bispebjerg Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Actual)

September 2, 2023

Study Completion (Actual)

April 1, 2024

Study Registration Dates

First Submitted

September 26, 2023

First Submitted That Met QC Criteria

September 26, 2023

First Posted (Actual)

October 3, 2023

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 08062023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Sharing IPD is not available as the data is protected by GDPR regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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