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Active, not recruiting Not applicable

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

NCT03435679 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2018-03-01
Last updated
2024-12-11

Condition(s) studied

Periprosthetic Knee Infection

Investigational drug(s) / intervention(s)

one-stagetwo-stage

one-stage: one-stage surgery

two-stage: two-stage surgery

Study 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.

Eligibility

Sex
ALL
Min age
—
Max age
—
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

Primary outcome measure(s)

  • Oxford Knee Score (AUC) — preoperatively 6 weeks, 3, 6, 9, 12 months postoperatively.
    Area Under Curve for Oxford Knee Score

Trial sites (9)

FacilityCityRegionStatus
Aalborg University Hospital Aalborg Denmark
Bispebjerg Hospital Copenhagen Denmark
Gentofte Hospital Copenhagen Denmark
Hvidovre Hospital Copenhagen Denmark
Rigshospitalet Copenhagen Denmark
Horsens Hospital Horsens Denmark
Næstved Hospital Næstved Denmark
Odense Universitets Hospital Odense Denmark
Vejle Hospital Vejle Denmark

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03435679 on ClinicalTrials.gov ↗ ← All trials in Denmark