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

Odense University Hospital

Status: Enrolling

Conditions: Periprosthetic Knee Infection

Treatments: Procedure: two-stage; Procedure: one-stage

Study type: Interventional

Funder types: Other

Identifiers

NCT03435679

MLL_02_2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

one-stage

Experimental group

Description:

one-stage surgical treatment of the infected knee arthroplasty

Treatment:

Procedure: one-stage

two-stage

Active Comparator group

Description:

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

Treatment:

Procedure: two-stage