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

O

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)

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

Trial contacts and locations

12

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Central trial contact

Martin Lindberg-Larsen, MD, PhD

Data sourced from clinicaltrials.gov

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