Clinical trial NCT04427943: Outcome After Revisions of Infected Knee Arthroplasties
Official title: Outcome After Revisions of Infected Knee Arthroplasties - a Prospective Multicenter Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Periprosthetic Knee Infection
Keywords: infection
knee arthroplasty
surgical treatment
patient reported outcome
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 350
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with periprosthetic knee joint infection requiring revision surgery.

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

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.

Eligibility criteria: 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"

Primary outcomes:
measure: Change in Oxford Knee Score (Area Under Curve (AUC) from preoperatively to 12 months postoperatively)
timeFrame: Measured preoperatively 6 weeks, 3, 6, 9, 12 months postoperatively
Secondary outcomes:
measure: Change in Oxford Knee Score (Area Under Curve, AUC from preop. to 12 months postop.)
timeFrame: Time Frame: Measured preoperatively, 6 weeks, 3, 6, 9, 12, 18 and 24 months postoperatively
measure: Change in EuroQol five-dimensional descriptive system (EQ-5D-5L) from preop to 24 months postop.
timeFrame: Measured preoperatively, 6 weeks, 3, 6, 9, 12, 18 and 24 months postoperatively.
measure: Number of participants re-revised (re-revision rate)
timeFrame: 2 year postoperatively
measure: Number of participants dying (mortality rate)
timeFrame: 2 years postoperatively
measure: Number of participants readmitted (readmission rate)
timeFrame: 90 days postoperatively
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
city: Copenhagen
country: Denmark
facility: Hvidovre
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Horsens
country: Denmark
facility: Horsens Hospital
city: Næstved
country: Denmark
facility: Næstved Hospital
city: Odense
country: Denmark
facility: Odense Universitets Hospital
city: Vejle
country: Denmark
facility: Vejle Hospital
Study officials:
affiliation: Odense University Hospital
name: Martin Lindberg-Larsen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: Lindberg-Larsen M, Odgaard A, Fredborg C, Schroder HM; One-stage vs Two-stage Collaboration Group. One-stage versus two-stage revision of the infected knee arthroplasty - a randomized multicenter clinical trial study protocol. BMC Musculoskelet Disord. 2021 Feb 12;22(1):175. doi: 10.1186/s12891-021-04044-8.