One-stage Versus Two-stage Revision of the Infected Knee Arthroplasty
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| ClinicalTrials.gov Identifier: NCT03435679 |
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Recruitment Status :
Recruiting
First Posted : February 19, 2018
Last Update Posted : August 30, 2019
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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 |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: one-stage
one-stage surgical treatment of the infected knee arthroplasty
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Procedure: one-stage
one-stage surgery |
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Active Comparator: two-stage
two-stage surgical treatment of the infected knee arthroplasty with a interim period of 8-10 weeks between stages
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Procedure: two-stage
two-stage surgery |
- 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
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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 25213900 | martin.lindberg-larsen@rsyd.dk |
| Denmark | |
| Aalborg University Hospital | Recruiting |
| Aalborg, Denmark | |
| Contact: Andreas Kappel, MD | |
| Aarhus University Hospital | Recruiting |
| Arhus, Denmark | |
| Contact: Claus Fink, MD | |
| Bispebjerg Hospital | Recruiting |
| Copenhagen, Denmark | |
| Contact: Jens Bagger, MD | |
| Gentofte Hospital | Recruiting |
| Copenhagen, Denmark | |
| Contact: Anders Odgaard, MD, PhD | |
| Horsens Hospital | Recruiting |
| Horsens, Denmark | |
| Contact: Jeppe Lange, MD, PhD | |
| Køge Hospital | Recruiting |
| Køge, Denmark | |
| Contact: Jesper Fabrin, MD | |
| Næstved Hospital | Recruiting |
| Næstved, Denmark | |
| Contact: Henrik Schrøder, MD | |
| Odense Universitets Hospital | Recruiting |
| Odense, Denmark | |
| Contact: Martin Lindberg-Larsen, MD, PhD | |
| Silkeborg Hospital | Recruiting |
| Silkeborg, Denmark | |
| Contact: Carsten Holm, MD | |
| Vejle Hospital | Recruiting |
| Vejle, Denmark | |
| Contact: Thomas Bruno Lind-Hansen, MD, PhD | |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Martin Lindberg-Larsen, Orthopaedic Surgeon, MD, PhD, Odense University Hospital |
| ClinicalTrials.gov Identifier: | NCT03435679 |
| Other Study ID Numbers: |
MLL_02_2018 |
| First Posted: | February 19, 2018 Key Record Dates |
| Last Update Posted: | August 30, 2019 |
| Last Verified: | August 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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infection knee arthroplasty surgical treatment |
one-stage two-stage outcome |
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Infection |