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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03435679
Recruitment Status : Recruiting
First Posted : February 19, 2018
Last Update Posted : August 30, 2019
Sponsor:
Collaborators:
Odense Patient Data Explorative Network
Region of Southern Denmark
Information provided by (Responsible Party):
Martin Lindberg-Larsen, Odense University Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Periprosthetic Knee Infection Procedure: one-stage Procedure: two-stage Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: One-stage Versus Two-stage Revision of the Infected Knee Arthroplasty. A Randomized Controlled Multicenter Trial.
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Oxford Knee Score (AUC) [ Time Frame: preoperatively 6 weeks, 3, 6, 9, 12 months postoperatively. ]
    Area Under Curve for Oxford Knee Score


Secondary Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03435679


Contacts
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Contact: Martin Lindberg-Larsen, MD, PhD 0045 25213900 martin.lindberg-larsen@rsyd.dk

Locations
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Denmark
Aalborg University Hospital Recruiting
Aalborg, Denmark
Contact: Andreas Kappel, MD         
Aarhus University Hospital Recruiting
Arhus, Denmark
Contact: Claus Fink, MD         
Bispebjerg Hospital Recruiting
Copenhagen, Denmark
Contact: Jens Bagger, MD         
Gentofte Hospital Recruiting
Copenhagen, Denmark
Contact: Anders Odgaard, MD, PhD         
Horsens Hospital Recruiting
Horsens, Denmark
Contact: Jeppe Lange, MD, PhD         
Køge Hospital Recruiting
Køge, Denmark
Contact: Jesper Fabrin, MD         
Næstved Hospital Recruiting
Næstved, Denmark
Contact: Henrik Schrøder, MD         
Odense Universitets Hospital Recruiting
Odense, Denmark
Contact: Martin Lindberg-Larsen, MD, PhD         
Silkeborg Hospital Recruiting
Silkeborg, Denmark
Contact: Carsten Holm, MD         
Vejle Hospital Recruiting
Vejle, Denmark
Contact: Thomas Bruno Lind-Hansen, MD, PhD         
Sponsors and Collaborators
Odense University Hospital
Odense Patient Data Explorative Network
Region of Southern Denmark
More Information
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Publications:

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Responsible Party: Martin Lindberg-Larsen, Orthopaedic Surgeon, MD, PhD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT03435679    
Other Study ID Numbers: MLL_02_2018
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Martin Lindberg-Larsen, Odense University Hospital:
infection
knee arthroplasty
surgical treatment
 one-stage
two-stage
outcome
Additional relevant MeSH terms:
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Infection