RIKA: Outcome After Revisions of Infected Knee Arthroplasties
Study Details
Study Description
Brief Summary
A prospective multicenter cohort study on all types of revision knee arthroplasty procedures performed due to infection.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Arms and Interventions
| Arm | 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.
|
Outcome Measures
Primary Outcome Measures
- Change in Oxford Knee Score (Area Under Curve (AUC) from preoperatively to 12 months postoperatively) [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 Outcome Measures
- 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]
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.
- 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.]
Quality of life questionnaire
- Number of participants re-revised (re-revision rate) [2 year postoperatively]
Number of patients re-revised due to infection and other causes within 2 years postoperatively.
- Number of participants dying (mortality rate) [2 years postoperatively]
Number of participants dying within 2 years posoperatively
- Number of participants readmitted (readmission rate) [90 days postoperatively]
Number of participant readmitted within 90 days postoperatively
Eligibility Criteria
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"
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Aalborg University Hospital | Aalborg | Denmark | ||
| 2 | Bispebjerg Hospital | Copenhagen | Denmark | ||
| 3 | Hvidovre | Copenhagen | Denmark | ||
| 4 | Rigshospitalet | Copenhagen | Denmark | ||
| 5 | Horsens Hospital | Horsens | Denmark | ||
| 6 | Næstved Hospital | Næstved | Denmark | ||
| 7 | Odense Universitets Hospital | Odense | Denmark | ||
| 8 | Vejle Hospital | Vejle | Denmark |
Sponsors and Collaborators
- Odense University Hospital
Investigators
- Principal Investigator: Martin Lindberg-Larsen, MD, PhD, Odense University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- S-20170108/69984