One-stage Versus Two-stage Revision of the Infected Knee Arthroplasty

Study Overview
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Brief Summary
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This study investigates functional outcome and safety after one-stage versus two-stage revision of the infected knee arthroplasty. Half of participants are treated with a one-stage surgical procedure, while the other half is treated with a two-stage procedure. The investigators hypothesize that the functional outcome and quality of life of the participants is superior after one-stage surgery compared to two-stage surgery.

Detailed Description
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A two-stage approach is the standard surgical procedure in the treatment of the chronically infected knee arthroplasty, but promising results have been reported after a one-stage approach from single-centre studies. The potential benefits for the patients treated with a one-stage approach are many as they only have to go through surgery and rehabilitation once with shorter total length of hospital stay. However, no randomized controlled trials comparing outcome after the procedures have been performed so far.

Official Title
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One-stage Versus Two-stage Revision of the Infected Knee Arthroplasty. A Randomized Controlled Multicenter Trial.

Conditions
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Periprosthetic Knee Infection

Intervention / Treatment
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* Procedure: one-stage
* Procedure: two-stage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical signs of periprosthetic knee infection > 6 weeks from previous knee arthoplasty procedure (primary or total revision procedure) Speak and understand Danish and have given informed consent Exclusion Criteria: Soft tissue problems requiring plastic surgery major bone loss requiring mega/tumor-prosthesis acute surgery due to sepsis malignant disease with less than 2 years life expectancy re-infection with previous two-stage procedure bilateral knee infection
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: one-stage<br>one-stage surgical treatment of the infected knee arthroplasty | Procedure: one-stage<br>* one-stage surgery<br>|
| Active Comparator: two-stage<br>two-stage surgical treatment of the infected knee arthroplasty with a interim period of 8-10 weeks between stages | Procedure: two-stage<br>* two-stage surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxford Knee Score (AUC) | Area Under Curve for Oxford Knee Score | preoperatively 6 weeks, 3, 6, 9, 12 months postoperatively. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxford Knee Score (AUC) | Area Under Curve for Oxford Knee Score | preoperatively, 6 weeks, 3, 6, 9, 12, 18 and 24 months postoperatively. | 
| EQ-5D-5L | Quality of life questionnaire | preoperatively, 6 weeks, 3, 6, 9, 12, 18 and 24 months postoperatively. | 
| Re-revision rate | re-revisions due to infection and other causes | 2 year postoperatively | 
| mortality | postoperative mortality | 90 days postoperatively and 1 and 2 year postoperatively | 
| readmission rate | postoperative readmission rate | 90 days postoperatively | 
| Range of Motion | Range of motion of the infected/operated knee | 2 years postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infection, knee arthroplasty, surgical treatment, one-stage, two-stage, outcome