Prosthesis-Related InfectionsNCT04304885
Effect of Sonication on Periprosthetic Joint Infection Treatment Strategy.
An observational study of Prosthesis-Related Infections and Hip Prosthesis Infection, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
It is not known in the literature how much sonication affects the patient's treatment. Another important issue is that the place of this method in diagnosis is not clear. The aim of this study is to contribute to the literature on this issue and to determine the sensitivity and specificity of sonication prospectively… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Prosthesis-Related Infections, Hip Prosthesis Infection, Joint Infection
- What is being tested?
- Sonication method
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2020to 15 Jan 2021
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients who have undergone primary hip and knee arthroplasty and will require revision for any reason.
Who may be able to join
- All patients scheduled for revision arthroplasty (aseptic revision, septic revision, instability, and periprosthetic fracture)
Who cannot join
- who do not accept to participate in research
- insufficient data for new definition criteria
- acute periprosthetic infections
- patients with systemic inflammatory disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bezmialem Vakif University
Istanbul, Fatih, 34000
Orkhan Aliyev, 05059917419, orkhanaliyev@outlook.com.tr
About this study
It is not known in the literature how much sonication affects the patient's treatment. Another important issue is that the place of this method in diagnosis is not clear. The aim of this study is to contribute to the literature on this issue and to determine the sensitivity and specificity of sonication prospectively using the new definition and effect of sonication on the treatment strategy in terms of infection in patients with PJI.
Read the detailed description
Total knee and hip arthroplasties are successful surgical procedures that are widely applied all over the world and provide high patient satisfaction and increased quality of life. Periprosthetic joint infection (PJI), is a serious complication that negatively affects the targeted result, decreases patient satisfaction, and increases morbidity and mortality after total joint replacement. Another important issue, the previous infection is the most important reason for the failure of surgery in revision arthroplasty. It is known that the success of PJI treatment seriously can be affected by the type of microorganism and antibiotic sensitivity. Therefore, microbiological examination methods are always of interest, and one of them is the sonication method.
- Being tested
- Sonication method
- Keywords
- total knee arthroplasty, complication, total hip arthroplasty, periprosthetic infection, revision arthroplasty, sonication, biofilm
- Medical subject headings
- Prosthesis-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonication methodDiagnostic test
Sonication dislodges adherent bacteria from explanted prosthetics by ultrasound and may improve the diagnosis of periprosthetic joint infection.
| Study group | Role | What they receive |
|---|---|---|
| Sonication method | The treatment strategies of all patients will be based on the cultural results to be made by the sonication method. Receives: Diagnostic Test: Sonication method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
To determine how many patients diagnosed with periprosthetic joint infection can be detected by sonication method.
Measured: 14 days
Secondary outcomes (1)
The change in antibiotic treatment.
In how many patients the sonication method will cause a change in treatment.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start15 Mar 2020
- Primary completion15 Jan 2021 (estimated)
- Study completion15 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prosthesis-Related InfectionsStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe 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
- 56 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Orkhan Aliyev, Bezmialem Vakif University
- Investigators
- Orkhan Aliyev, MD, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04304885
- Sponsor's protocol ID
- 28.02.2020-02
- Status last verified
- Jan 2021
- First submitted
- 8 Mar 2020
- Last updated
- 7 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aliyev O, Yildiz F, Kaya HB, Aghazada A, Sumbul B, Citak M, Tuncay I. Sonication of explants enhances the diagnostic accuracy of synovial fluid and tissue cultures and can help determine the appropriate antibiotic therapy for prosthetic joint infections. Int Orthop. 2022 Mar;46(3):415-422. doi: 10.1007/s00264-021-05286-w. Epub 2022 Jan 24.
PubMed 35067748
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sonication on Periprosthetic Joint Infection Treatment Strategy.
- ClinicalTrials.gov ID
- NCT04304885
- Acronym / sponsor ID
- 28.02.2020-02
- Keywords
- total knee arthroplasty, complication, total hip arthroplasty, periprosthetic infection, revision arthroplasty, sonication, biofilm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 15 Jan 2021 (estimated)
- Study completion
- 15 Jan 2021 (estimated)
- First posted
- 12 Mar 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.
It is not known in the literature how much sonication affects the patient's treatment. Another important issue is that the place of this method in diagnosis is not clear. The aim of this study is to contribute to the literature on this issue and to determine the sensitivity and specificity of sonication prospectively using the new definition and effect of sonication on the treatment strategy in terms of infection in patients with PJI.
Detailed description
Total knee and hip arthroplasties are successful surgical procedures that are widely applied all over the world and provide high patient satisfaction and increased quality of life. Periprosthetic joint infection (PJI), is a serious complication that negatively affects the targeted result, decreases patient satisfaction, and increases morbidity and mortality after total joint replacement. Another important issue, the previous infection is the most important reason for the failure of surgery in revision arthroplasty. It is known that the success of PJI treatment seriously can be affected by the type of microorganism and antibiotic sensitivity. Therefore, microbiological examination methods are always of interest, and one of them is the sonication method.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sonication method | – | Diagnostic Test: Sonication methodThe treatment strategies of all patients will be based on the cultural results to be made by the sonication method. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who have undergone primary hip and knee arthroplasty and will require revision for any reason.
Key inclusion criteria (1 listed)
- All patients scheduled for revision arthroplasty (aseptic revision, septic revision, instability, and periprosthetic fracture)
Key exclusion criteria (4 listed)
- who do not accept to participate in research
- insufficient data for new definition criteria
- acute periprosthetic infections
- patients with systemic inflammatory disease
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 |
|---|---|---|
| Sonication methodSonication dislodges adherent bacteria from explanted prosthetics by ultrasound and may improve the diagnosis of periprosthetic joint infection. | Diagnostic test | Sonication method |
Primary outcome
Sensitivity
Time frame: 14 days
To determine how many patients diagnosed with periprosthetic joint infection can be detected by sonication method.
1 secondary outcome
The change in antibiotic treatment.
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2021.
- Derived from this study: PubMed 35067748Aliyev O, Yildiz F, Kaya HB, Aghazada A, Sumbul B, Citak M, Tuncay I. Sonication of explants enhances the diagnostic accuracy of synovial fluid and tissue cultures and can help determine the appropriate antibiotic therapy for prosthetic joint infections. Int Orthop. 2022 Mar;46(3):415-422. doi: 10.1007/s00264-021-05286-w. Epub 2022 Jan 24.
- Individual participant dataSharing planned: No
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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.
Orkhan Aliyev, MD principal investigator
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prosthesis-Related Infections and Hip Prosthesis Infection, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 7 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatih Yildiz, MD (+905059917419, yildizfatih@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: 14 days). 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 NCT04304885, which also lists 1 linked publication.
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 7 Jan 2021.