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

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT06064318
Collaborator
Odense University Hospital (Other), Bispebjerg Hospital (Other)
165,000
Enrollment
1
Location
10.9
Anticipated Duration (Months)
15081.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Revision

Study Design

Study Type:
Observational
Anticipated Enrollment :
165000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Prevalence and Incidence of Multiple Revisions Following Knee Arthroplasty in Denmark 1998-2021: A Nationwide Population-based Study
Actual Study Start Date :
Feb 1, 2023
Actual Primary Completion Date :
Sep 2, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Prevalence of major n-grade revisions [23 years]

    standardized prevalence of major n-grade revisions

  2. Incidence of major n-grade revisions [23 years]

    standardized incidence of major n-grade revisions

  3. Prevalence of all n-grade revisions [23 years]

    standardized prevalence of all n-grade revisions

  4. Incidence of all n-grade revisions [23 years]

    standardized incidence of all n-grade revisions

Secondary Outcome Measures

  1. Incidence of major and all n-grade revisions stratified by sex and age [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)

  2. Prevalence of major and all n-grade revisions stratified by sex and age [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)

  3. Prevalence of major and all n-grade revisions for patients with their total sum of revisions [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rigshospitalet Copenhagen Denmark 2100

Sponsors and Collaborators

  • Rigshospitalet, Denmark
  • Odense University Hospital
  • Bispebjerg Hospital

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Julius Tetens Hald, Dr., Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT06064318
Other Study ID Numbers:
  • 08062023
First Posted:
Oct 3, 2023
Last Update Posted:
Oct 3, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 3, 2023