跳至主要内容
临床试验/NCT04427943
NCT04427943进行中(未招募)不适用

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

Odense University Hospital8 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
350
试验地点
8
主要终点
Change in Oxford Knee Score (Area Under Curve (AUC) from preoperatively to 12 months postoperatively)

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Clinical signs of periprosthetic knee joint infection and indication for revision surgery
  • Speak and understand Danish and have given informed consent

排除标准

  • Participation in "one-stage versus two-stage revisions of the infected knee arthroplasty"

结局指标

主要结局

Change in Oxford Knee Score (Area Under Curve (AUC) from preoperatively to 12 months postoperatively)

时间窗: 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.

次要结局

  • Change in EuroQol five-dimensional descriptive system (EQ-5D-5L) from preop to 24 months postop.(Measured preoperatively, 6 weeks, 3, 6, 9, 12, 18 and 24 months postoperatively.)
  • Number of participants dying (mortality rate)(2 years postoperatively)
  • Change in Oxford Knee Score (Area Under Curve, AUC from preop. to 12 months postop.)(Time Frame: Measured preoperatively, 6 weeks, 3, 6, 9, 12, 18 and 24 months postoperatively)
  • Number of participants readmitted (readmission rate)(90 days postoperatively)
  • Number of participants re-revised (re-revision rate)(2 year postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Martin Lindberg-Larsen

Principal investigator

Odense University Hospital

研究点 (8)

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