Outcome After Revisions of Infected Knee Arthroplasties (RIKA)

April 12, 2024 updated by: Martin Lindberg-Larsen, Odense University Hospital

Outcome After Revisions of Infected Knee Arthroplasties - a Prospective Multicenter Cohort Study

A prospective multicenter cohort study on all types of revision knee arthroplasty procedures performed due to infection.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A prospective multicenter cohort study on all types of revision knee arthroplasty procedures performed due to infection.

Most previous studies investigating outcomes after revisions of infected knee artrplasties are single-center studies and retrospective. The study group has previously investigated outcome of the surgical treatment of infected knee arthroplasties in Denmark based on nationwide data from Danish registries. These studies revealed that the risk of treatment failure causing re-revision or mortality was 30-40% in Denmark.

Based on these findings, an ongoing randomized controlled trial "one-stage versus two-stage revisions of the infected knee arthroplasty" (ClinicalTrials.gov ID: NCT03435679) has been initiated by the study group in Febuary 2018. It has been possible to include 20% of the patients with surgically demanding periprosthetic knee infections from the including centres in this randomized trial due to in- and exclusions criteria. Hence, the investigators wish to include the remaining patients with periprosthetic knee joint infection in a prospective cohort study in order to obtain high quality prospective data on function, quality of life and complications after all types of surgical procedures performed due to periprosthetic knee joint infection. Based on these data it will be possible to evaluate the surgical treatment overall and it will be possible to evaluate whether the patients included in the randomized trial are representative.

Study aim:

To present patient reported outcome and postoperative complications after all types of surgical procedures performed due to periprosthetic knee infection. Furthermore, to analyze the role of potential risk factors (patient comorbidity, microbiological diagnosis, surgical intervention, antibiotic treatment, duration of symptoms) on outcome of the patients.

Study Type

Observational

Enrollment (Estimated)

350

Contacts and Locations

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

Study Contact

Study Locations

  • Denmark
      • Aalborg, Denmark
        • Recruiting
        • Aalborg University Hospital
        • Contact:
      • Copenhagen, Denmark
        • Not yet recruiting
        • Rigshospitalet
        • Contact:
      • Copenhagen, Denmark
        • Recruiting
        • Bispebjerg Hospital
        • Contact:
      • Copenhagen, Denmark
        • Recruiting
        • Hvidovre
        • Contact:
          • Kirill Gromov
      • Horsens, Denmark
        • Recruiting
        • Horsens Hospital
        • Contact:
      • Næstved, Denmark
        • Recruiting
        • Næstved Hospital
        • Contact:
      • Odense, Denmark
      • Vejle, Denmark

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients with periprosthetic knee joint infection requiring revision surgery.

Description

Inclusion Criteria:

  • Clinical signs of periprosthetic knee joint infection and indication for revision surgery
  • Speak and understand Danish and have given informed consent

Exclusion Criteria:

  • Participation in "one-stage versus two-stage revisions of the infected knee arthroplasty"

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
RIKA cohort
patients with periprosthetic knee joint infection scheduled for revision knee arthroplasty surgery
Procedure: revision surgery
The intervention is the planned revision surgery according to local guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Oxford Knee Score (Area Under Curve (AUC) from preoperatively to 12 months postoperatively)
Time Frame: Measured preoperatively 6 weeks, 3, 6, 9, 12 months postoperatively
Change in Oxford Knee Score from preoperatively to 12 months postoperatively measured as Area Under Curve. Oxford Knee Score ranges from 0 to 48, 48 = best score.
Measured preoperatively 6 weeks, 3, 6, 9, 12 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Oxford Knee Score (Area Under Curve, AUC from preop. to 12 months postop.)
Time Frame: Time Frame: Measured preoperatively, 6 weeks, 3, 6, 9, 12, 18 and 24 months postoperatively
Change in Oxford Knee Score from preoperatively to 24 months postoperatively measured as Area Under Curve. Oxford Knee Score ranges from 0 to 48, 48 = best score.
Time Frame: Measured preoperatively, 6 weeks, 3, 6, 9, 12, 18 and 24 months postoperatively
Change in EuroQol five-dimensional descriptive system (EQ-5D-5L) from preop to 24 months postop.
Time Frame: Measured preoperatively, 6 weeks, 3, 6, 9, 12, 18 and 24 months postoperatively.
Quality of life questionnaire
Measured preoperatively, 6 weeks, 3, 6, 9, 12, 18 and 24 months postoperatively.
Number of participants re-revised (re-revision rate)
Time Frame: 2 year postoperatively
Number of patients re-revised due to infection and other causes within 2 years postoperatively.
2 year postoperatively
Number of participants dying (mortality rate)
Time Frame: 2 years postoperatively
Number of participants dying within 2 years posoperatively
2 years postoperatively
Number of participants readmitted (readmission rate)
Time Frame: 90 days postoperatively
Number of participant readmitted within 90 days postoperatively
90 days postoperatively

Collaborators and Investigators

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

Sponsor

Odense University Hospital

Investigators

  • Principal Investigator: Martin Lindberg-Larsen, MD, PhD, Odense University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2020

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

January 8, 2020

First Submitted That Met QC Criteria

June 10, 2020

First Posted (Actual)

June 11, 2020

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-20170108/69984

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

According to local interpretation of GDPR. Blided data can be provided upon request.

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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