Outcome After Revisions of Infected Knee Arthroplasties (RIKA)
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| ClinicalTrials.gov Identifier: NCT04427943 |
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Recruitment Status :
Recruiting
First Posted : June 11, 2020
Last Update Posted : June 11, 2020
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| Condition or disease | Intervention/treatment |
|---|---|
| Periprosthetic Knee Infection | Procedure: revision surgery |
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 Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 350 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 2 Years |
| Official Title: | Outcome After Revisions of Infected Knee Arthroplasties - a Prospective Multicenter Cohort Study |
| Actual Study Start Date : | January 1, 2020 |
| Estimated Primary Completion Date : | January 1, 2025 |
| Estimated Study Completion Date : | January 1, 2026 |
| Group/Cohort | Intervention/treatment |
|---|---|
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RIKA cohort
patients with periprosthetic knee joint infection scheduled for revision knee arthroplasty surgery
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Procedure: revision surgery
The intervention is the planned revision surgery according to local guidelines. |
- 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.
- Change in Oxford Knee Score (Area Under Curve, AUC from preop. to 12 months postop.) [ Time Frame: 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. [ Time Frame: 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) [ Time Frame: 2 year postoperatively ]Number of patients re-revised due to infection and other causes within 2 years postoperatively.
- Number of participants dying (mortality rate) [ Time Frame: 2 years postoperatively ]Number of participants dying within 2 years posoperatively
- Number of participants readmitted (readmission rate) [ Time Frame: 90 days postoperatively ]Number of participant readmitted within 90 days postoperatively
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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"
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04427943
| Contact: Martin Lindberg-Larsen, MD, PhD | 0045 25213900 | martin.lindberg-larsen@rsyd.dk |
| Denmark | |
| Aalborg University Hospital | Recruiting |
| Aalborg, Denmark | |
| Contact: Andreas Kappel, MD 004520604629 andreas.kappel@rn.dk | |
| Bispebjerg Hospital | Recruiting |
| Copenhagen, Denmark | |
| Contact: Jens Bagger, MD 21603580 jens.bagger@regionh.dk | |
| Rigshospitalet | Not yet recruiting |
| Copenhagen, Denmark | |
| Contact: Anders Odgaard, MD, PhD 0045 27478245 anders.odgaard@regionh.dk | |
| Horsens Hospital | Recruiting |
| Horsens, Denmark | |
| Contact: Jeppe Lange, MD, PhD 0045 26853290 jeppe.lange@clin.au.dk | |
| Næstved Hospital | Recruiting |
| Næstved, Denmark | |
| Contact: Henrik Schrøder, MD 0045 50567163 hemsc@regionsjaelland.dk | |
| Odense Universitets Hospital | Recruiting |
| Odense, Denmark | |
| Contact: Martin Lindberg-Larsen, MD, PhD 0045 25213900 martin.lindberg-larsen@rsyd.dk | |
| Vejle Hospital | Recruiting |
| Vejle, Denmark | |
| Contact: Thomas Bruno Lind-Hansen, MD, PhD 0045 22289260 Thomas.Bruno.Lind-Hansen@rsyd.dk | |
| Principal Investigator: | Martin Lindberg-Larsen, MD, PhD | Odense University Hospital, Denmark |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Martin Lindberg-Larsen, Principal investigator, Odense University Hospital |
| ClinicalTrials.gov Identifier: | NCT04427943 |
| Other Study ID Numbers: |
S-20170108/69984 |
| First Posted: | June 11, 2020 Key Record Dates |
| Last Update Posted: | June 11, 2020 |
| Last Verified: | June 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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infection knee arthroplasty surgical treatment patient reported outcome |
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Infection |