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Outcome After Revisions of Infected Knee Arthroplasties (RIKA)

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ClinicalTrials.gov Identifier: NCT04427943
Recruitment Status : Recruiting
First Posted : June 11, 2020
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Martin Lindberg-Larsen, Odense University Hospital

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

Condition or disease Intervention/treatment
Periprosthetic Knee Infection Procedure: revision surgery

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Group/Cohort 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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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

  3. 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.

  4. Number of participants dying (mortality rate) [ Time Frame: 2 years postoperatively ]
    Number of participants dying within 2 years posoperatively

  5. Number of participants readmitted (readmission rate) [ Time Frame: 90 days postoperatively ]
    Number of participant readmitted within 90 days postoperatively



Information from the National Library of Medicine

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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
Study Population
Patients with periprosthetic knee joint infection requiring revision surgery.
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"

Information from the National Library of Medicine

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


Contacts
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Contact: Martin Lindberg-Larsen, MD, PhD 0045 25213900 martin.lindberg-larsen@rsyd.dk

Locations
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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   
Sponsors and Collaborators
Odense University Hospital
Investigators
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Principal Investigator: Martin Lindberg-Larsen, MD, PhD Odense University Hospital, Denmark
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Martin Lindberg-Larsen, Odense University Hospital:
infection
knee arthroplasty
surgical treatment
patient reported outcome
Additional relevant MeSH terms:
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Infection