Periprosthetic Knee InfectionRIKANCT04427943
Outcome After Revisions of Infected Knee Arthroplasties
An observational study of Periprosthetic Knee Infection, run by Odense University Hospital at 8 sites in Denmark.
Trial summary
A prospective multicenter cohort study on all types of revision knee arthroplasty procedures performed due to infection. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Periprosthetic Knee Infection
- What is being tested?
- revision surgery
- Type of treatment
- Surgery or procedure
- How many people
- 350 participants
- Where
- 8 sitesDenmark
- Study dates
- 1 Jan 2020to Nov 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with periprosthetic knee joint infection requiring revision surgery.
Who may be able to join
- Clinical signs of periprosthetic knee joint infection and indication for revision surgery
- Speak and understand Danish and have given informed consent
Who cannot join
- Participation in "one-stage versus two-stage revisions of the infected knee arthroplasty"
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Denmark8 sites
Aalborg University Hospital
Aalborg
Bispebjerg Hospital
Copenhagen
Hvidovre
Copenhagen
Rigshospitalet
Copenhagen
Horsens Hospital
Horsens
Næstved Hospital
Næstved
Odense Universitets Hospital
Odense
Vejle Hospital
Vejle
About this study
Official title: Outcome After Revisions of Infected Knee Arthroplasties - a Prospective Multicenter Cohort Study
A prospective multicenter cohort study on all types of revision knee arthroplasty procedures performed due to infection.
Read the detailed description
A prospective multicenter cohort study on all types of revision knee arthroplasty procedures performed due to infection.
Most previous studies investigating outcomes after revisions of infected knee artrplasties are single-center studies and retrospective. The study group has previously investigated outcome of the surgical treatment of infected knee arthroplasties in Denmark based on nationwide data from Danish registries. These studies revealed that the risk of treatment failure causing re-revision or mortality was 30-40% in Denmark.
Based on these findings, an ongoing randomized controlled trial "one-stage versus two-stage revisions of the infected knee arthroplasty" (ClinicalTrials.gov ID: NCT03435679) has been initiated by the study group in Febuary 2018. It has been possible to include 20% of the patients with surgically demanding periprosthetic knee infections from the including centres in this randomized trial due to in- and exclusions criteria. Hence, the investigators wish to include the remaining patients with periprosthetic knee joint infection in a prospective cohort study in order to obtain high quality prospective data on function, quality of life and complications after all types of surgical procedures performed due to periprosthetic knee joint infection. Based on these data it will be possible to evaluate the surgical treatment overall and it will be possible to evaluate whether the patients included in the randomized trial are representative.
Study aim:
To present patient reported outcome and postoperative complications after all types of surgical procedures performed due to periprosthetic knee infection. Furthermore, to analyze the role of potential risk factors (patient comorbidity, microbiological diagnosis, surgical intervention, antibiotic treatment, duration of symptoms) on outcome of the patients.
- Conditions
- Periprosthetic Knee Infection
- Being tested
- revision surgery
- Keywords
- infection, knee arthroplasty, surgical treatment, patient reported outcome
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
revision surgeryProcedure or surgery
The intervention is the planned revision surgery according to local guidelines.
| Study group | Role | What they receive |
|---|---|---|
| RIKA cohort | patients with periprosthetic knee joint infection scheduled for revision knee arthroplasty surgery Receives: Procedure: revision surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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.)
Change in Oxford Knee Score from preoperatively to 24 months postoperatively measured as Area Under Curve. Oxford Knee Score ranges from 0 to 48, 48 = best score.
Measured: 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.
Quality of life questionnaire
Measured: Measured preoperatively, 6 weeks, 3, 6, 9, 12, 18 and 24 months postoperatively.
Number of participants re-revised (re-revision rate)
Number of patients re-revised due to infection and other causes within 2 years postoperatively.
Measured: 2 year postoperatively
Number of participants dying (mortality rate)
Number of participants dying within 2 years posoperatively
Measured: 2 years postoperatively
Number of participants readmitted (readmission rate)
Number of participant readmitted within 90 days postoperatively
Measured: 90 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Jan 2020
- Primary completionNov 2025 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Periprosthetic Knee InfectionStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Lindberg-Larsen, Odense University Hospital
- Investigators
- Martin Lindberg-Larsen, MD, PhD, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04427943
- Sponsor's protocol ID
- S-20170108/69984
- Acronym
- RIKA
- Status last verified
- Dec 2024
- First submitted
- 8 Jan 2020
- 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. Blided data can be provided upon request.
Publications
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 28691647Lindberg-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 26900908Lindberg-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
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome After Revisions of Infected Knee Arthroplasties - a Prospective Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT04427943
- Acronym / sponsor ID
- RIKA / S-20170108/69984
- Conditions
- Periprosthetic Knee Infection
- Keywords
- infection, knee arthroplasty, surgical treatment, patient reported outcome
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective multicenter cohort study on all types of revision knee arthroplasty procedures performed due to infection.
Detailed description
A prospective multicenter cohort study on all types of revision knee arthroplasty procedures performed due to infection.
Most previous studies investigating outcomes after revisions of infected knee artrplasties are single-center studies and retrospective. The study group has previously investigated outcome of the surgical treatment of infected knee arthroplasties in Denmark based on nationwide data from Danish registries. These studies revealed that the risk of treatment failure causing re-revision or mortality was 30-40% in Denmark.
Based on these findings, an ongoing randomized controlled trial "one-stage versus two-stage revisions of the infected knee arthroplasty" (ClinicalTrials.gov ID: NCT03435679) has been initiated by the study group in Febuary 2018. It has been possible to include 20% of the patients with surgically demanding periprosthetic knee infections from the including centres in this randomized trial due to in- and exclusions criteria. Hence, the investigators wish to include the remaining patients with periprosthetic knee joint infection in a prospective cohort study in order to obtain high quality prospective data on function, quality of life and complications after all types of surgical procedures performed due to periprosthetic knee joint infection. Based on these data it will be possible to evaluate the surgical treatment overall and it will be possible to evaluate whether the patients included in the randomized trial are representative.
Study aim:
To present patient reported outcome and postoperative complications after all types of surgical procedures performed due to periprosthetic knee infection. Furthermore, to analyze the role of potential risk factors (patient comorbidity, microbiological diagnosis, surgical intervention, antibiotic treatment, duration of symptoms) on outcome of the patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RIKA cohort | – | Procedure: revision surgerypatients with periprosthetic knee joint infection scheduled for revision knee arthroplasty surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with periprosthetic knee joint infection requiring revision surgery.
Key inclusion criteria (2 listed)
- Clinical signs of periprosthetic knee joint infection and indication for revision surgery
- Speak and understand Danish and have given informed consent
Key exclusion criteria (1 listed)
- Participation in "one-stage versus two-stage revisions of the infected knee arthroplasty"
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| revision surgeryThe intervention is the planned revision surgery according to local guidelines. | Procedure or surgery | RIKA cohort |
Primary outcome
Change in Oxford Knee Score (Area Under Curve (AUC) from preoperatively to 12 months postoperatively)
Time frame: Measured preoperatively 6 weeks, 3, 6, 9, 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.
5 secondary outcomes
Change in Oxford Knee Score (Area Under Curve, AUC from preop. to 12 months postop.)
Time frame: 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.
Time frame: Measured preoperatively, 6 weeks, 3, 6, 9, 12, 18 and 24 months postoperatively.
Number of participants re-revised (re-revision rate)
Time frame: 2 year postoperatively
Number of participants dying (mortality rate)
Time frame: 2 years postoperatively
Number of participants readmitted (readmission rate)
Time frame: 90 days postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Results publication: PubMed 28691647Lindberg-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.
- Results publication: PubMed 26900908Lindberg-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.
- Derived from this study: PubMed 33579256Lindberg-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.
- Individual participant dataSharing planned: No. According to local interpretation of GDPR. Blided data can be provided upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Lindberg-Larsen, MD, PhD principal investigator
Odense University Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periprosthetic Knee Infection, run by Odense University Hospital at 8 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 2 inclusion and 1 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 8 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?
Change in Oxford Knee Score (Area Under Curve (AUC) from preoperatively to 12 months postoperatively) (time frame: Measured 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 NCT04427943, which also lists 3 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.