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A prospective multicenter cohort study on all types of revision knee arthroplasty procedures performed due to infection.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RIKA cohort | patients with periprosthetic knee joint infection scheduled for revision knee arthroplasty surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| revision surgery | Procedure | The intervention is the planned revision surgery according to local guidelines. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with periprosthetic knee joint infection requiring revision surgery.
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| Name | Affiliation | Role |
|---|---|---|
| Martin Lindberg-Larsen, MD, PhD | Odense University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital | Aalborg | Denmark | ||||
| Bispebjerg Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28691647 | Result | 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. | |
| 26900908 | Result | 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. |
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According to local interpretation of GDPR. Blided data can be provided upon request.
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| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| D012086 | Reoperation |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| 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. |
| 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 |
| Number of participants dying (mortality rate) | Number of participants dying within 2 years posoperatively | 2 years postoperatively |
| Number of participants readmitted (readmission rate) | Number of participant readmitted within 90 days postoperatively | 90 days postoperatively |
| Copenhagen |
| Denmark |
| Hvidovre | Copenhagen | Denmark |
| Rigshospitalet | Copenhagen | Denmark |
| Horsens Hospital | Horsens | Denmark |
| Næstved Hospital | Næstved | Denmark |
| Odense Universitets Hospital | Odense | Denmark |
| Vejle Hospital | Vejle | Denmark |
| 33579256 | Derived | 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. |