Clinical trial NCT03435679: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Periprosthetic Knee Infection
Keywords: infection
knee arthroplasty
surgical treatment
one-stage
two-stage
outcome
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Odense Patient Data Explorative Network
name: Region of Southern Denmark
First posted: 2018-02-19
Enrollment: 97
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Oxford Knee Score (AUC)
timeFrame: preoperatively 6 weeks, 3, 6, 9, 12 months postoperatively.
Secondary outcomes:
measure: Oxford Knee Score (AUC)
timeFrame: preoperatively, 6 weeks, 3, 6, 9, 12, 18 and 24 months postoperatively.
measure: EQ-5D-5L
timeFrame: preoperatively, 6 weeks, 3, 6, 9, 12, 18 and 24 months postoperatively.
measure: Re-revision rate
timeFrame: 2 year postoperatively
measure: mortality
timeFrame: 90 days postoperatively and 1 and 2 year postoperatively
measure: readmission rate
timeFrame: 90 days postoperatively
measure: Range of Motion
timeFrame: 2 years postoperatively
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
city: Copenhagen
country: Denmark
facility: Gentofte Hospital
city: Copenhagen
country: Denmark
facility: Hvidovre Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Horsens
country: Denmark
facility: Horsens Hospital
city: Næstved
country: Denmark
facility: Næstved Hospital
city: Odense
country: Denmark
facility: Odense Universitets Hospital
city: Vejle
country: Denmark
facility: Vejle Hospital
Study officials:
affiliation: Martin Lindberg-Larsen
name: Martin Lindberg-Larsen
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.