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CompletedNCT06064318EMKAR ONEUpdated Jun 4, 2025

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

An observational study in Knee Replacement and Knee Replacement Revision, sponsored by Rigshospitalet, Denmark. Completed at 1 site in Denmark. Per ClinicalTrials.gov, last updated 2025-06-04.

Sponsored by Rigshospitalet, Denmark · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
161,384
Sex
All
01

Study 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.

02

Conditions studied

  • Knee Replacement
  • Knee Replacement Revision
03

In context

Lead sponsor

Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

All Danish residents who received a primary knee arthroplasty in Denmark between 1998-2021.

Inclusion criteria

  • Danish Resident
  • all ages
  • must have had primary knee arthroplasty procedure performed in Denmark between 1998-2021

Exclusion criteria

Exclusion Criteria:

  • Missing key variables (patient ID, date of surgery, procedure-code, laterality of procedure)
  • Duplicates
  • Non-relevant procedures
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
161,384 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • ProcedureRevision

    Any type of knee revision, excluding knee arthrodesis and femur amputation

06

What researchers measure

Primary outcomes

  1. Prevalence of major n-grade revisions

    standardized prevalence of major n-grade revisions

    Time frame: 23 years

  2. Incidence of major n-grade revisions

    standardized incidence of major n-grade revisions

    Time frame: 23 years

  3. Prevalence of all n-grade revisions

    standardized prevalence of all n-grade revisions

    Time frame: 23 years

  4. Incidence of all n-grade revisions

    standardized incidence of all n-grade revisions

    Time frame: 23 years

Secondary outcomes

  1. 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)

    Time frame: 23 years

  2. 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)

    Time frame: 23 years

  3. 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

    Time frame: 23 Years

07

Study locations

1 site
  • Rigshospitalet
    Copenhagen, 2100, Denmark
08

References and documents

Study documents

  • Study protocol · Jun 12, 2023
  • Statistical analysis plan · Jul 28, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — Sharing IPD is not available as the data is protected by GDPR regulations.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06064318
Lead sponsor
Rigshospitalet, Denmark
Collaborators
Odense University Hospital, Bispebjerg Hospital
Responsible party
Julius Tetens Hald (Dr., Rigshospitalet, Denmark) — Principal investigator
First posted
Oct 3, 2023
Start date
Feb 1, 2023
Primary completion
Sep 2, 2023
Completion
Apr 1, 2024
Last update
Jun 4, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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