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NCT Number: NCT04427943

Outcome After Revisions of Infected Knee Arthroplasties

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Periprosthetic Knee Infection Infections

Sex eligibility

All sexes

Study type

Observational

Primary location

Aalborg University Hospital, Aalborg, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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"

Treatment and study plan

revision surgery

Procedure

The intervention is the planned revision surgery according to local guidelines.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. Number of participants dying (mortality rate)

    Time frame: 2 years postoperatively

    Number of participants dying within 2 years posoperatively

  5. Number of participants readmitted (readmission rate)

    Time frame: 90 days postoperatively

    Number of participant readmitted within 90 days postoperatively

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Official study title

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

Acronym: RIKA

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Jun 11, 2020
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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