Outcome After Revisions of Infected Knee Arthroplasties
NCT ID: NCT04427943
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
350 participants
OBSERVATIONAL
2020-01-01
2026-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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RIKA cohort
patients with periprosthetic knee joint infection scheduled for revision knee arthroplasty surgery
revision surgery
The intervention is the planned revision surgery according to local guidelines.
Interventions
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revision surgery
The intervention is the planned revision surgery according to local guidelines.
Eligibility Criteria
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Inclusion Criteria
* Speak and understand Danish and have given informed consent
Exclusion Criteria
ALL
Yes
Sponsors
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Odense University Hospital
OTHER
Responsible Party
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Martin Lindberg-Larsen
Principal investigator
Principal Investigators
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Martin Lindberg-Larsen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Odense University Hospital
Locations
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Aalborg University Hospital
Aalborg, , Denmark
Bispebjerg Hospital
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
Countries
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References
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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.
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.
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.
Other Identifiers
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S-20170108/69984
Identifier Type: -
Identifier Source: org_study_id