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

Primary Purpose

Periprosthetic Knee Infection

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
one-stage
two-stage
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periprosthetic Knee Infection focused on measuring infection, knee arthroplasty, surgical treatment, one-stage, two-stage, outcome

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Aalborg University HospitalRecruiting
  • Aarhus University Hospital
  • Bispebjerg HospitalRecruiting
  • Gentofte HospitalRecruiting
  • Hvidovre HospitalRecruiting
  • RigshospitaletRecruiting
  • Horsens HospitalRecruiting
  • Køge Hospital
  • Næstved HospitalRecruiting
  • Odense Universitets HospitalRecruiting
  • Silkeborg Hospital
  • Vejle HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

one-stage

two-stage

Arm Description

one-stage surgical treatment of the infected knee arthroplasty

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

Outcomes

Primary Outcome Measures

Oxford Knee Score (AUC)
Area Under Curve for Oxford Knee Score

Secondary Outcome Measures

Oxford Knee Score (AUC)
Area Under Curve for Oxford Knee Score
EQ-5D-5L
Quality of life questionnaire
Re-revision rate
re-revisions due to infection and other causes
mortality
postoperative mortality
readmission rate
postoperative readmission rate
Range of Motion
Range of motion of the infected/operated knee

Full Information

First Posted
January 31, 2018
Last Updated
August 26, 2021
Sponsor
Odense University Hospital
Collaborators
Odense Patient Data Explorative Network, Region of Southern Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT03435679
Brief Title
One-stage Versus Two-stage Revision of the Infected Knee Arthroplasty
Official Title
One-stage Versus Two-stage Revision of the Infected Knee Arthroplasty. A Randomized Controlled Multicenter Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital
Collaborators
Odense Patient Data Explorative Network, Region of Southern Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periprosthetic Knee Infection
Keywords
infection, knee arthroplasty, surgical treatment, one-stage, two-stage, outcome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
one-stage
Arm Type
Experimental
Arm Description
one-stage surgical treatment of the infected knee arthroplasty
Arm Title
two-stage
Arm Type
Active Comparator
Arm Description
two-stage surgical treatment of the infected knee arthroplasty with a interim period of 8-10 weeks between stages
Intervention Type
Procedure
Intervention Name(s)
one-stage
Intervention Description
one-stage surgery
Intervention Type
Procedure
Intervention Name(s)
two-stage
Intervention Description
two-stage surgery
Primary Outcome Measure Information:
Title
Oxford Knee Score (AUC)
Description
Area Under Curve for Oxford Knee Score
Time Frame
preoperatively 6 weeks, 3, 6, 9, 12 months postoperatively.
Secondary Outcome Measure Information:
Title
Oxford Knee Score (AUC)
Description
Area Under Curve for Oxford Knee Score
Time Frame
preoperatively, 6 weeks, 3, 6, 9, 12, 18 and 24 months postoperatively.
Title
EQ-5D-5L
Description
Quality of life questionnaire
Time Frame
preoperatively, 6 weeks, 3, 6, 9, 12, 18 and 24 months postoperatively.
Title
Re-revision rate
Description
re-revisions due to infection and other causes
Time Frame
2 year postoperatively
Title
mortality
Description
postoperative mortality
Time Frame
90 days postoperatively and 1 and 2 year postoperatively
Title
readmission rate
Description
postoperative readmission rate
Time Frame
90 days postoperatively
Title
Range of Motion
Description
Range of motion of the infected/operated knee
Time Frame
2 years postoperatively

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Lindberg-Larsen, MD, PhD
Phone
0045 25213900
Email
martin.lindberg-larsen@rsyd.dk
Facility Information:
Facility Name
Aalborg University Hospital
City
Aalborg
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas Kappel, MD
Facility Name
Aarhus University Hospital
City
Arhus
Country
Denmark
Individual Site Status
Withdrawn
Facility Name
Bispebjerg Hospital
City
Copenhagen
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Morten Smiegalow, MD
Facility Name
Gentofte Hospital
City
Copenhagen
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anders Odgaard, MD, PhD
Facility Name
Hvidovre Hospital
City
Copenhagen
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirill Gromov, MD, PhD
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anders Odgaard, Professor
Facility Name
Horsens Hospital
City
Horsens
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeppe Lange, MD, PhD
Facility Name
Køge Hospital
City
Køge
Country
Denmark
Individual Site Status
Withdrawn
Facility Name
Næstved Hospital
City
Næstved
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henrik Schrøder, MD
Facility Name
Odense Universitets Hospital
City
Odense
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Lindberg-Larsen, MD, PhD
Facility Name
Silkeborg Hospital
City
Silkeborg
Country
Denmark
Individual Site Status
Withdrawn
Facility Name
Vejle Hospital
City
Vejle
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Bruno Lind-Hansen, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26900908
Citation
Lindberg-Larsen M, Jorgensen CC, Bagger J, Schroder HM, Kehlet H. Revision of infected knee arthroplasties in Denmark. Acta Orthop. 2016 Aug;87(4):333-8. doi: 10.3109/17453674.2016.1148453. Epub 2016 Feb 22.
Results Reference
background
PubMed Identifier
28691647
Citation
Lindberg-Larsen M, Pitter FT, Voldstedlund M, Schroder HM, Bagger J. Microbiological diagnosis in revision of infected knee arthroplasties in Denmark. Infect Dis (Lond). 2017 Nov-Dec;49(11-12):824-830. doi: 10.1080/23744235.2017.1350878. Epub 2017 Jul 8.
Results Reference
background
PubMed Identifier
23895421
Citation
Masters JP, Smith NA, Foguet P, Reed M, Parsons H, Sprowson AP. A systematic review of the evidence for single stage and two stage revision of infected knee replacement. BMC Musculoskelet Disord. 2013 Jul 29;14:222. doi: 10.1186/1471-2474-14-222.
Results Reference
background
PubMed Identifier
24923669
Citation
Haddad FS, Sukeik M, Alazzawi S. Is single-stage revision according to a strict protocol effective in treatment of chronic knee arthroplasty infections? Clin Orthop Relat Res. 2015 Jan;473(1):8-14. doi: 10.1007/s11999-014-3721-8.
Results Reference
background
PubMed Identifier
22081299
Citation
Singer J, Merz A, Frommelt L, Fink B. High rate of infection control with one-stage revision of septic knee prostheses excluding MRSA and MRSE. Clin Orthop Relat Res. 2012 May;470(5):1461-71. doi: 10.1007/s11999-011-2174-6. Epub 2011 Nov 12.
Results Reference
background
PubMed Identifier
22692517
Citation
Baker P, Petheram TG, Kurtz S, Konttinen YT, Gregg P, Deehan D. Patient reported outcome measures after revision of the infected TKR: comparison of single versus two-stage revision. Knee Surg Sports Traumatol Arthrosc. 2013 Dec;21(12):2713-20. doi: 10.1007/s00167-012-2090-7. Epub 2012 Jun 13.
Results Reference
background
PubMed Identifier
26611899
Citation
Massin P, Delory T, Lhotellier L, Pasquier G, Roche O, Cazenave A, Estellat C, Jenny JY. Infection recurrence factors in one- and two-stage total knee prosthesis exchanges. Knee Surg Sports Traumatol Arthrosc. 2016 Oct;24(10):3131-3139. doi: 10.1007/s00167-015-3884-1. Epub 2015 Nov 26.
Results Reference
background
PubMed Identifier
33579256
Citation
Lindberg-Larsen M, Odgaard A, Fredborg C, Schroder HM; One-stage vs Two-stage Collaboration Group. One-stage versus two-stage revision of the infected knee arthroplasty - a randomized multicenter clinical trial study protocol. BMC Musculoskelet Disord. 2021 Feb 12;22(1):175. doi: 10.1186/s12891-021-04044-8.
Results Reference
derived

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

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