NCT06064318

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
161,384

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2023

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 26, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 3, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

June 4, 2025

Status Verified

June 1, 2025

Enrollment Period

7 months

First QC Date

September 26, 2023

Last Update Submit

June 3, 2025

Conditions

Knee ReplacementKnee Replacement Revision

Outcome Measures

Primary Outcomes (4)

  • Prevalence of major n-grade revisions

    standardized prevalence of major n-grade revisions

    23 years

  • Incidence of major n-grade revisions

    standardized incidence of major n-grade revisions

    23 years

  • Prevalence of all n-grade revisions

    standardized prevalence of all n-grade revisions

    23 years

  • Incidence of all n-grade revisions

    standardized incidence of all n-grade revisions

    23 years

Secondary Outcomes (3)

  • Incidence of major and all n-grade revisions stratified by sex and age

    23 years

  • Prevalence of major and all n-grade revisions stratified by sex and age

    23 years

  • Prevalence of major and all n-grade revisions for patients with their total sum of revisions

    23 Years

Study Arms (2)

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

RevisionPROCEDURE

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

Revision cohort

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Interventions

Second-Look Surgery

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

September 26, 2023

First Posted

October 3, 2023

Study Start

February 1, 2023

Primary Completion

September 2, 2023

Study Completion

April 1, 2024

Last Updated

June 4, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

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

Locations

DK(1)