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

NCT03435679 | Active Not Recruiting DMC

• 1 other identifier: MLL_02_2018
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 9

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.

Conditions

Periprosthetic Knee Infection

Keywords

infection; knee arthroplasty; surgical treatment; one-stage; two-stage; outcome

Outcome Measures

Primary Outcomes (1)

• Oxford Knee Score (AUC)

  Area Under Curve for Oxford Knee Score

  preoperatively 6 weeks, 3, 6, 9, 12 months postoperatively.

Secondary Outcomes (6)

• Oxford Knee Score (AUC)

  preoperatively, 6 weeks, 3, 6, 9, 12, 18 and 24 months postoperatively.

• EQ-5D-5L

  preoperatively, 6 weeks, 3, 6, 9, 12, 18 and 24 months postoperatively.

• Re-revision rate

  2 year postoperatively

• mortality

  90 days postoperatively and 1 and 2 year postoperatively

• readmission rate

  90 days postoperatively

Study Arms (2)

one-stage

EXPERIMENTAL

one-stage surgical treatment of the infected knee arthroplasty

Procedure: one-stage

two-stage

ACTIVE COMPARATOR

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

Procedure: two-stage

Interventions

one-stage PROCEDURE

one-stage surgery

one-stage

two-stage PROCEDURE

two-stage surgery

two-stage

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Odense University Hospital: lead
• Odense Patient Data Explorative Network: collaborator
• Region of Southern Denmark: collaborator

Study Sites (9)

Aalborg University Hospital

Aalborg, Denmark

Location

Bispebjerg Hospital

Copenhagen, Denmark

Location

Gentofte Hospital

Copenhagen, Denmark

Location

Hvidovre Hospital

Copenhagen, Denmark

Location

Rigshospitalet

Copenhagen, Denmark

Location

Horsens Hospital

Horsens, Denmark

Location

Næstved Hospital

Næstved, Denmark

Location

Odense Universitets Hospital

Odense, Denmark

Location

Vejle Hospital

Vejle, Denmark

Location

Related Publications (8)

• 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.

  PMID: 26900908 BACKGROUND

• 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.

  PMID: 28691647 BACKGROUND

• 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.

  PMID: 23895421 BACKGROUND

• 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.

  PMID: 24923669 BACKGROUND

• 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.

  PMID: 22081299 BACKGROUND

• 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.

  PMID: 22692517 BACKGROUND

• 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.

  PMID: 26611899 BACKGROUND

• 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.

  PMID: 33579256 DERIVED

MeSH Terms

Conditions

Infections

Study Officials

• Martin Lindberg-Larsen

  Martin Lindberg-Larsen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Surgeon, MD, PhD

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: February 19, 2018
• Study Start: March 1, 2018
• Primary Completion: November 18, 2025
• Study Completion (Estimated): November 18, 2026
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (9)