One-stage Versus Two-stage Revision of the Infected Knee Arthroplasty
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03435679|
Recruitment Status : Recruiting
First Posted : February 19, 2018
Last Update Posted : August 30, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Periprosthetic Knee Infection||Procedure: one-stage Procedure: two-stage||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||One-stage Versus Two-stage Revision of the Infected Knee Arthroplasty. A Randomized Controlled Multicenter Trial.|
|Actual Study Start Date :||March 1, 2018|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||March 2023|
one-stage surgical treatment of the infected knee arthroplasty
Active Comparator: two-stage
two-stage surgical treatment of the infected knee arthroplasty with a interim period of 8-10 weeks between stages
- Oxford Knee Score (AUC) [ Time Frame: preoperatively 6 weeks, 3, 6, 9, 12 months postoperatively. ]Area Under Curve for Oxford Knee Score
- Oxford Knee Score (AUC) [ Time Frame: preoperatively, 6 weeks, 3, 6, 9, 12, 18 and 24 months postoperatively. ]Area Under Curve for Oxford Knee Score
- EQ-5D-5L [ Time Frame: preoperatively, 6 weeks, 3, 6, 9, 12, 18 and 24 months postoperatively. ]Quality of life questionnaire
- Re-revision rate [ Time Frame: 2 year postoperatively ]re-revisions due to infection and other causes
- mortality [ Time Frame: 90 days postoperatively and 1 and 2 year postoperatively ]postoperative mortality
- readmission rate [ Time Frame: 90 days postoperatively ]postoperative readmission rate
- Range of Motion [ Time Frame: 2 years postoperatively ]Range of motion of the infected/operated knee
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03435679
|Contact: Martin Lindberg-Larsen, MD, PhD||0045 firstname.lastname@example.org|
|Aalborg University Hospital||Recruiting|
|Contact: Andreas Kappel, MD|
|Aarhus University Hospital||Recruiting|
|Contact: Claus Fink, MD|
|Contact: Jens Bagger, MD|
|Contact: Anders Odgaard, MD, PhD|
|Contact: Jeppe Lange, MD, PhD|
|Contact: Jesper Fabrin, MD|
|Contact: Henrik Schrøder, MD|
|Odense Universitets Hospital||Recruiting|
|Contact: Martin Lindberg-Larsen, MD, PhD|
|Contact: Carsten Holm, MD|
|Contact: Thomas Bruno Lind-Hansen, MD, PhD|