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Periprosthetic Knee InfectionNCT03435679

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

A study testing one-stage and two-stage in people with Periprosthetic Knee Infection, run by Odense University Hospital at 9 sites in Denmark.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Periprosthetic Knee Infection
What is being tested?
one-stage and two-stage
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
97 participants
Where
9 sitesDenmark
Study dates
1 Mar 2018to 18 Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Denmark9 sites

  • Aalborg University Hospital

    Aalborg

  • Bispebjerg Hospital

    Copenhagen

  • Gentofte Hospital

    Copenhagen

  • Hvidovre Hospital

    Copenhagen

  • Rigshospitalet

    Copenhagen

  • Horsens Hospital

    Horsens

  • Næstved Hospital

    Næstved

  • Odense Universitets Hospital

    Odense

  • Vejle Hospital

    Vejle

Other trials in Denmark

About this study

Official title: One-stage Versus Two-stage Revision of the Infected Knee Arthroplasty. a Randomized Controlled Multicenter Trial.

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.

Read the detailed 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.

Being tested
one-stage, two-stage
Keywords
infection, knee arthroplasty, surgical treatment, one-stage, two-stage, outcome
Medical subject headings
Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • one-stageProcedure or surgery

    one-stage surgery

  • two-stageProcedure or surgery

    two-stage surgery

Study groups in NCT03435679
Study groupRoleWhat they receive
one-stageExperimentalone-stage surgical treatment of the infected knee arthroplasty
Receives: Procedure: one-stage
two-stageActive comparatortwo-stage surgical treatment of the infected knee arthroplasty with a interim period of 8-10 weeks between stages
Receives: Procedure: two-stage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Oxford Knee Score (AUC)

    Area Under Curve for Oxford Knee Score

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

Secondary outcomes (6)

  1. Oxford Knee Score (AUC)

    Area Under Curve for Oxford Knee Score

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

  2. EQ-5D-5L

    Quality of life questionnaire

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

  3. Re-revision rate

    re-revisions due to infection and other causes

    Measured: 2 year postoperatively

  4. mortality

    postoperative mortality

    Measured: 90 days postoperatively and 1 and 2 year postoperatively

  5. readmission rate

    postoperative readmission rate

    Measured: 90 days postoperatively

  6. Range of Motion

    Range of motion of the infected/operated knee

    Measured: 2 years postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2018
  2. Study start1 Mar 2018
  3. Primary completion18 Nov 2025 (estimated)
  4. Study completion18 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
97 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03435679
Sponsor's protocol ID
MLL_02_2018
Status last verified
Dec 2024
First submitted
31 Jan 2018
Last updated
11 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: According to local interpretation of GDPR. Blinded data can be provided upon request.

Publications

  • 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.

    PubMed 26900908

  • 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.

    PubMed 28691647

  • 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.

    PubMed 23895421

  • 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.

    PubMed 24923669

  • 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.

    PubMed 22081299

  • 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.

    PubMed 22692517

  • 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.

    PubMed 26611899

  • 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.

    PubMed 33579256

Questions about this trial

What is this clinical trial studying?

A study testing one-stage and two-stage in people with Periprosthetic Knee Infection, run by Odense University Hospital at 9 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oxford Knee Score (AUC) (time frame: preoperatively 6 weeks, 3, 6, 9, 12 months postoperatively.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03435679, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.

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