Knee ReplacementEMKAR ONENCT06064318
Prevalence and Incidence of Multiple Revisions Following Knee Arthroplasty in Denmark 1998-2021: A Nationwide Population-based Study
An observational study of Knee Replacement and Knee Replacement Revision, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Knee Replacement, Knee Replacement Revision
- What is being tested?
- Revision
- Type of treatment
- Surgery or procedure
- How many people
- 161,384 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2023to 1 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All Danish residents who received a primary knee arthroplasty in Denmark between 1998-2021.
Who may be able to join
- Danish Resident
- all ages
- must have had primary knee arthroplasty procedure performed in Denmark between 1998-2021
Who cannot join
- Missing key variables (patient ID, date of surgery, procedure-code, laterality of procedure)
- Duplicates
- Non-relevant procedures
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the incidence and prevalence rates of multiply revised knee arthroplasty patients in Denmark from 1998-2021.
- Conditions
- Knee Replacement, Knee Replacement Revision
- Being tested
- Revision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RevisionProcedure or surgery
Any type of knee revision, excluding knee arthrodesis and femur amputation
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Revision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of major n-grade revisions
standardized prevalence of major n-grade revisions
Measured: 23 years
Incidence of major n-grade revisions
standardized incidence of major n-grade revisions
Measured: 23 years
Prevalence of all n-grade revisions
standardized prevalence of all n-grade revisions
Measured: 23 years
Incidence of all n-grade revisions
standardized incidence of all n-grade revisions
Measured: 23 years
Secondary outcomes (3)
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)
Measured: 23 years
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)
Measured: 23 years
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
Measured: 23 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start1 Feb 2023
- Primary completion2 Sep 2023
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ReplacementStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 161,384 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, Bispebjerg Hospital
- Responsible party
- Principal investigator, Julius Tetens Hald, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06064318
- Sponsor's protocol ID
- 08062023
- Acronym
- EMKAR ONE
- Status last verified
- Jun 2025
- First submitted
- 26 Sep 2023
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing IPD is not available as the data is protected by GDPR regulations.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Incidence of Multiple Revisions Following Knee Arthroplasty in Denmark 1998-2021: A Nationwide Population-based Study
- ClinicalTrials.gov ID
- NCT06064318
- Acronym / sponsor ID
- EMKAR ONE / 08062023
- Conditions
- Knee Replacement, Knee Replacement Revision
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161,384 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Odense University Hospital, Bispebjerg Hospital
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 2 Sep 2023 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 3 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary cohort | – | –All patients with a primary knee arthroplasty performed in Denmark between Jan 1st 1998 and 31st December 2021. |
| Revision cohort | – | Procedure: RevisionAll patients with a revision knee arthroplasty performed in Denmark between Jan 1st 1998 and 31st December 2021 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All Danish residents who received a primary knee arthroplasty in Denmark between 1998-2021.
Key inclusion criteria (3 listed)
- Danish Resident
- all ages
- must have had primary knee arthroplasty procedure performed in Denmark between 1998-2021
Key exclusion criteria (3 listed)
- Missing key variables (patient ID, date of surgery, procedure-code, laterality of procedure)
- Duplicates
- Non-relevant procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RevisionAny type of knee revision, excluding knee arthrodesis and femur amputation | Procedure or surgery | Revision cohort |
Primary outcome
Prevalence of major n-grade revisions
Time frame: 23 years
standardized prevalence of major n-grade revisions
Incidence of major n-grade revisions
Time frame: 23 years
standardized incidence of major n-grade revisions
Prevalence of all n-grade revisions
Time frame: 23 years
standardized prevalence of all n-grade revisions
Incidence of all n-grade revisions
Time frame: 23 years
standardized incidence of all n-grade revisions
3 secondary outcomes
Incidence of major and all n-grade revisions stratified by sex and age
Time frame: 23 years
Prevalence of major and all n-grade revisions stratified by sex and age
Time frame: 23 years
Prevalence of major and all n-grade revisions for patients with their total sum of revisions
Time frame: 23 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: No. Sharing IPD is not available as the data is protected by GDPR regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Replacement and Knee Replacement Revision, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of major n-grade revisions (time frame: 23 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.