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

April 12, 2024 updated by: Martin Lindberg-Larsen, Odense University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
      • Aalborg, Denmark
        • Recruiting
        • Aalborg University Hospital
        • Contact:
          • Andreas Kappel, MD
      • Arhus, Denmark
        • Withdrawn
        • Aarhus University Hospital
      • Copenhagen, Denmark
        • Recruiting
        • Rigshospitalet
        • Contact:
          • Anders Odgaard, Professor
      • Copenhagen, Denmark
        • Recruiting
        • Bispebjerg Hospital
        • Contact:
          • Morten Smiegalow, MD
      • Copenhagen, Denmark
        • Recruiting
        • Gentofte Hospital
        • Contact:
          • Anders Odgaard, MD, PhD
      • Copenhagen, Denmark
        • Recruiting
        • Hvidovre Hospital
        • Contact:
          • Kirill Gromov, MD, PhD
      • Horsens, Denmark
        • Recruiting
        • Horsens Hospital
        • Contact:
          • Jeppe Lange, MD, PhD
      • Køge, Denmark
        • Withdrawn
        • Køge Hospital
      • Næstved, Denmark
        • Recruiting
        • Næstved Hospital
        • Contact:
          • Henrik Schrøder, MD
      • Odense, Denmark
        • Recruiting
        • Odense Universitets Hospital
        • Contact:
          • Martin Lindberg-Larsen, MD, PhD
      • Silkeborg, Denmark
        • Withdrawn
        • Silkeborg Hospital
      • Vejle, Denmark
        • Recruiting
        • Vejle Hospital
        • Contact:
          • Thomas Bruno Lind-Hansen, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: one-stage
one-stage surgical treatment of the infected knee arthroplasty
Procedure: one-stage
one-stage surgery
Active Comparator: two-stage
two-stage surgical treatment of the infected knee arthroplasty with a interim period of 8-10 weeks between stages
Procedure: two-stage
two-stage surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxford Knee Score (AUC)
Time Frame: preoperatively 6 weeks, 3, 6, 9, 12 months postoperatively.
Area Under Curve for Oxford Knee Score
preoperatively 6 weeks, 3, 6, 9, 12 months postoperatively.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
preoperatively, 6 weeks, 3, 6, 9, 12, 18 and 24 months postoperatively.
EQ-5D-5L
Time Frame: preoperatively, 6 weeks, 3, 6, 9, 12, 18 and 24 months postoperatively.
Quality of life questionnaire
preoperatively, 6 weeks, 3, 6, 9, 12, 18 and 24 months postoperatively.
Re-revision rate
Time Frame: 2 year postoperatively
re-revisions due to infection and other causes
2 year postoperatively
mortality
Time Frame: 90 days postoperatively and 1 and 2 year postoperatively
postoperative mortality
90 days postoperatively and 1 and 2 year postoperatively
readmission rate
Time Frame: 90 days postoperatively
postoperative readmission rate
90 days postoperatively
Range of Motion
Time Frame: 2 years postoperatively
Range of motion of the infected/operated knee
2 years postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Collaborators

Region of Southern Denmark
Odense Patient Data Explorative Network

Investigators

  • Principal Investigator: Martin Lindberg-Larsen, Martin Lindberg-Larsen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

January 31, 2018

First Submitted That Met QC Criteria

February 9, 2018

First Posted (Actual)

February 19, 2018

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MLL_02_2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

According to local interpretation of GDPR. Blinded data can be provided upon request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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