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

Not Applicable

Active, not recruiting

• Conditions: Periprosthetic Knee Infection
• Interventions: Procedure: one-stage; Procedure: two-stage

• Registration Number: NCT03435679
• Lead Sponsor: Odense University Hospital

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.

Study Timeline

• Study First Submitted: 2018-01-31
• Study First Submitted QC: 2018-02-09
• Study First Posted: 2018-02-19
• Study Start: 2018-03-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-11
• Primary Completion: 2025-11-18
• Study Completion: 2026-11-18

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 97

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
one-stage	one-stage	one-stage surgical treatment of the infected knee arthroplasty
two-stage	two-stage	two-stage surgical treatment of the infected knee arthroplasty with a interim period of 8-10 weeks between stages

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (9)

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