Status:
ACTIVE_NOT_RECRUITING
One-stage Versus Two-stage Revision of the Infected Knee Arthroplasty
Lead Sponsor:
Odense University Hospital
Collaborating Sponsors:
Odense Patient Data Explorative Network
Region of Southern Denmark
Conditions:
Periprosthetic Knee Infection
Eligibility:
All Genders
Phase:
NA
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...
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-...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 18 2026
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT03435679
Start Date
March 1 2018
End Date
November 18 2026
Last Update
December 11 2024
Active Locations (9)
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1
Aalborg University Hospital
Aalborg, Denmark
2
Bispebjerg Hospital
Copenhagen, Denmark
3
Gentofte Hospital
Copenhagen, Denmark
4
Hvidovre Hospital
Copenhagen, Denmark