One-stage Versus Two-stage Revision of the Infected Knee Arthroplasty
NCT ID: NCT03435679
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
97 participants
INTERVENTIONAL
2018-03-01
2026-11-18
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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one-stage
one-stage surgical treatment of the infected knee arthroplasty
one-stage
one-stage surgery
two-stage
two-stage surgical treatment of the infected knee arthroplasty with a interim period of 8-10 weeks between stages
two-stage
two-stage surgery
Interventions
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one-stage
one-stage surgery
two-stage
two-stage surgery
Eligibility Criteria
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Inclusion Criteria
* \> 6 weeks from previous knee arthoplasty procedure (primary or total revision procedure)
* Speak and understand Danish and have given informed consent
Exclusion Criteria
* 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
ALL
No
Sponsors
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Odense Patient Data Explorative Network
OTHER
Region of Southern Denmark
OTHER
Odense University Hospital
OTHER
Responsible Party
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Martin Lindberg-Larsen
Orthopaedic Surgeon, MD, PhD
Principal Investigators
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Martin Lindberg-Larsen
Role: PRINCIPAL_INVESTIGATOR
Martin Lindberg-Larsen
Locations
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Aalborg University Hospital
Aalborg, , Denmark
Bispebjerg Hospital
Copenhagen, , Denmark
Gentofte Hospital
Copenhagen, , Denmark
Hvidovre Hospital
Copenhagen, , Denmark
Rigshospitalet
Copenhagen, , Denmark
Horsens Hospital
Horsens, , Denmark
Næstved Hospital
Næstved, , Denmark
Odense Universitets Hospital
Odense, , Denmark
Vejle Hospital
Vejle, , Denmark
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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MLL_02_2018
Identifier Type: -
Identifier Source: org_study_id