Outcome After Revisions of Infected Knee Arthroplasties

Periprosthetic Knee Infection Clinical Trial

— RIKA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04427943
• Other study ID #: S-20170108/69984
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: January 1, 2027

Study information

• Verified date: April 2024
• Source: Odense University Hospital
• Contact: Martin Lindberg-Larsen, MD, PhD
• Phone: 0045 25213900
• Email: martin.lindberg-larsen[@]rsyd.dk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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"

Related Conditions & MeSH terms

• Infections
• Periprosthetic Knee Infection

Intervention

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

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg
Denmark	Bispebjerg Hospital	Copenhagen
Denmark	Hvidovre	Copenhagen
Denmark	Rigshospitalet	Copenhagen
Denmark	Horsens Hospital	Horsens
Denmark	Næstved Hospital	Næstved
Denmark	Odense Universitets Hospital	Odense
Denmark	Vejle Hospital	Vejle

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

Lindberg-Larsen M, Jorgensen CC, Bagger J, Schroder HM, Kehlet H. Revision of infected knee arthroplasties in Denmark. Acta Orthop. 2016 Aug;87(4):333-8. doi: 10.3109/17453674.2016.1148453. Epub 2016 Feb 22. — View Citation

Lindberg-Larsen M, Pitter FT, Voldstedlund M, Schroder HM, Bagger J. Microbiological diagnosis in revision of infected knee arthroplasties in Denmark. Infect Dis (Lond). 2017 Nov-Dec;49(11-12):824-830. doi: 10.1080/23744235.2017.1350878. Epub 2017 Jul 8. — View Citation

Outcome

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