Outcome After Revisions of Infected Knee Arthroplasties - a Prospective Multicenter Cohort Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Odense University Hospital
- Enrollment
- 350
- Locations
- 8
- Primary Endpoint
- Change in Oxford Knee Score (Area Under Curve (AUC) from preoperatively to 12 months postoperatively)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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"
Outcomes
Primary Outcomes
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
- Change in EuroQol five-dimensional descriptive system (EQ-5D-5L) from preop to 24 months postop.(Measured preoperatively, 6 weeks, 3, 6, 9, 12, 18 and 24 months postoperatively.)
- Number of participants dying (mortality rate)(2 years postoperatively)
- Change in Oxford Knee Score (Area Under Curve, AUC from preop. to 12 months postop.)(Time Frame: Measured preoperatively, 6 weeks, 3, 6, 9, 12, 18 and 24 months postoperatively)
- Number of participants readmitted (readmission rate)(90 days postoperatively)
- Number of participants re-revised (re-revision rate)(2 year postoperatively)
Investigators
Martin Lindberg-Larsen
Principal investigator
Odense University Hospital