Outcome After Revisions of Infected Knee Arthroplasties

NCT04427943 | Active Not Recruiting DMC

• 1 other identifier: S-20170108/69984
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 8

Brief Summary

A prospective multicenter cohort study on all types of revision knee arthroplasty procedures performed due to infection.

Conditions

Periprosthetic Knee Infection

Keywords

infection; knee arthroplasty; surgical treatment; patient reported outcome

Outcome Measures

Primary Outcomes (1)

• Change in Oxford Knee Score (Area Under Curve (AUC) from preoperatively to 12 months postoperatively)

  Change in Oxford Knee Score from preoperatively to 12 months postoperatively measured as Area Under Curve. Oxford Knee Score ranges from 0 to 48, 48 = best score.

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

Secondary Outcomes (5)

• Change in Oxford Knee Score (Area Under Curve, AUC from preop. to 12 months postop.)

  Time Frame: Measured preoperatively, 6 weeks, 3, 6, 9, 12, 18 and 24 months postoperatively

• Change in EuroQol five-dimensional descriptive system (EQ-5D-5L) from preop to 24 months postop.

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

• Number of participants re-revised (re-revision rate)

  2 year postoperatively

• Number of participants dying (mortality rate)

  2 years postoperatively

• Number of participants readmitted (readmission rate)

  90 days postoperatively

Study Arms (1)

RIKA cohort

patients with periprosthetic knee joint infection scheduled for revision knee arthroplasty surgery

Procedure: revision surgery

Interventions

revision surgery PROCEDURE

The intervention is the planned revision surgery according to local guidelines.

RIKA cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with periprosthetic knee joint infection requiring revision surgery.

You may qualify if:

• Clinical signs of periprosthetic knee joint infection and indication for revision surgery
• Speak and understand Danish and have given informed consent

You may not qualify if:

• Participation in "one-stage versus two-stage revisions of the infected knee arthroplasty"

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (8)

Aalborg University Hospital

Aalborg, Denmark

Location

Bispebjerg Hospital

Copenhagen, Denmark

Location

Hvidovre

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 (3)

• 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

• 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, 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

Interventions

Reoperation

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Martin Lindberg-Larsen, MD, PhD

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: June 11, 2020
• Study Start: January 1, 2020
• Primary Completion: November 1, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (8)