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NCT Number: NCT03435679

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Periprosthetic Knee Infection Infections

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg University Hospital, Aalborg, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

one-stage

Procedure

one-stage surgery

two-stage

Procedure

two-stage surgery

Primary outcomes

  1. Oxford Knee Score (AUC)

    Time frame: preoperatively 6 weeks, 3, 6, 9, 12 months postoperatively.

    Area Under Curve for Oxford Knee Score

Secondary outcomes

  1. Oxford Knee Score (AUC)

    Time frame: preoperatively, 6 weeks, 3, 6, 9, 12, 18 and 24 months postoperatively.

    Area Under Curve for Oxford Knee Score

  2. EQ-5D-5L

    Time frame: preoperatively, 6 weeks, 3, 6, 9, 12, 18 and 24 months postoperatively.

    Quality of life questionnaire

  3. Re-revision rate

    Time frame: 2 year postoperatively

    re-revisions due to infection and other causes

  4. mortality

    Time frame: 90 days postoperatively and 1 and 2 year postoperatively

    postoperative mortality

  5. readmission rate

    Time frame: 90 days postoperatively

    postoperative readmission rate

  6. Range of Motion

    Time frame: 2 years postoperatively

    Range of motion of the infected/operated knee

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

  • Odense Patient Data Explorative Network
  • Region of Southern Denmark

Registry information

Official study title

One-stage Versus Two-stage Revision of the Infected Knee Arthroplasty. a Randomized Controlled Multicenter Trial.

Important dates

Study start
2018
Primary completion
2025
Study completion
2026
First posted
Feb 19, 2018
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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