Periprosthetic Knee Infection
Conditions
Keywords
infection, knee arthroplasty, surgical treatment, one-stage, two-stage, outcome
Brief summary
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
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.
Sponsors
Odense Patient Data Explorative Network
Region of Southern Denmark
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxford Knee Score (AUC) | preoperatively 6 weeks, 3, 6, 9, 12 months postoperatively. | Area Under Curve for Oxford Knee Score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EQ-5D-5L | preoperatively, 6 weeks, 3, 6, 9, 12, 18 and 24 months postoperatively. | Quality of life questionnaire |
| Re-revision rate | 2 year postoperatively | re-revisions due to infection and other causes |
| Oxford Knee Score (AUC) | preoperatively, 6 weeks, 3, 6, 9, 12, 18 and 24 months postoperatively. | Area Under Curve for Oxford Knee Score |
| readmission rate | 90 days postoperatively | postoperative readmission rate |
| Range of Motion | 2 years postoperatively | Range of motion of the infected/operated knee |
| mortality | 90 days postoperatively and 1 and 2 year postoperatively | postoperative mortality |
Countries
Denmark
Outcome results
None listed