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Active Not RecruitingNCT04427943

Outcome After Revisions of Infected Knee Arthroplasties

Outcome After Revisions of Infected Knee Arthroplasties - a Prospective Multicenter Cohort Study

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
350 (estimated)
Sponsor
Odense University Hospital · Academic / Other
Sex
All
Age
Healthy volunteers
Accepted

Summary

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

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.

Conditions

Interventions

TypeNameDescription
PROCEDURErevision surgeryThe intervention is the planned revision surgery according to local guidelines.

Timeline

Start date
2020-01-01
Primary completion
2025-11-01
Completion
2026-11-01
First posted
2020-06-11
Last updated
2024-12-11

Locations

8 sites across 1 country: Denmark

Source: ClinicalTrials.gov record NCT04427943. Inclusion in this directory is not an endorsement.