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

Periprosthetic Knee Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03435679
• Other study ID #: MLL_02_2018
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: March 1, 2027

Study information

• Verified date: April 2024
• Source: Odense University Hospital
• Contact: Martin Lindberg-Larsen, MD, PhD
• Phone: 0045 25213900
• Email: martin.lindberg-larsen[@]rsyd.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: March 1, 2027
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Infections
• Periprosthetic Knee Infection

Intervention

Procedure:
• one-stage
one-stage surgery
• two-stage
two-stage surgery

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg
Denmark	Aarhus University Hospital	Arhus
Denmark	Bispebjerg Hospital	Copenhagen
Denmark	Gentofte Hospital	Copenhagen
Denmark	Hvidovre Hospital	Copenhagen
Denmark	Rigshospitalet	Copenhagen
Denmark	Horsens Hospital	Horsens
Denmark	Køge Hospital	Køge
Denmark	Næstved Hospital	Næstved
Denmark	Odense Universitets Hospital	Odense
Denmark	Silkeborg Hospital	Silkeborg
Denmark	Vejle Hospital	Vejle

Sponsors (3)

Lead Sponsor	Collaborator
Odense University Hospital	Odense Patient Data Explorative Network, Region of Southern Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxford Knee Score (AUC)	Area Under Curve for Oxford Knee Score	preoperatively 6 weeks, 3, 6, 9, 12 months postoperatively.
Secondary	Oxford Knee Score (AUC)	Area Under Curve for Oxford Knee Score	preoperatively, 6 weeks, 3, 6, 9, 12, 18 and 24 months postoperatively.
Secondary	EQ-5D-5L	Quality of life questionnaire	preoperatively, 6 weeks, 3, 6, 9, 12, 18 and 24 months postoperatively.
Secondary	Re-revision rate	re-revisions due to infection and other causes	2 year postoperatively
Secondary	mortality	postoperative mortality	90 days postoperatively and 1 and 2 year postoperatively
Secondary	readmission rate	postoperative readmission rate	90 days postoperatively
Secondary	Range of Motion	Range of motion of the infected/operated knee	2 years postoperatively