SonicationNCT02853461
Biofilm Investigation on Bearing Components of Explanted Hip Joint Prosthesis
An observational study of Sonication and Total Hip Replacement, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
In this study the investigators sonicate the bearing components of the explanted hip prosthesis which allows highly sensitive detection of in vivo biofilms (qualitatively and quantitatively). The hip prosthesis bearing components are composed from different material. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sonication, Total Hip Replacement, Biofilm
- What is being tested?
- Sonication and Microbiological analysis
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2014to Mar 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients ≥18 y, undergoing hip prosthesis explantation for infection or mechanical (aseptic) reason.
Who may be able to join
- Subject must be aged 18 or more.
- Subject must be scheduled to undergo an explanation of the hip endoprosthesis during the 1- or 2- stage revision procedure because of the septic or mechanical indication.
- Subject must personally sign and date the informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
Who cannot join
- Patient not scheduled for the index Operation procedure with removal of hip endoprosthesis
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Charité Universitätsmedizin Berlin
Berlin, State of Berlin, 10117
Andrej Trampuz, MD, +49 30 450 615 073, andrej.trampuz@charite.de
About this study
Official title: Biofilm Investigation on Ceramic, Metal and Polyethylene Bearing Components From Explanted Hip Joint Prosthesis
In this study the investigators sonicate the bearing components of the explanted hip prosthesis which allows highly sensitive detection of in vivo biofilms (qualitatively and quantitatively). The hip prosthesis bearing components are composed from different material. The purpose of this study is to analyse the resistance against biofilm adhesion of ceramic, metal and polyethylene prosthesis components through microbiologic analysis of sonicates.
Read the detailed description
The main reasons for hip prosthesis failure are aseptic loosening and periprosthetic joint infection (PJI). The real frequency of PJI is probably largely underestimated because of non-standardized definition criteria, diagnostic procedure, treatment algorithm and other confounders. Therefore, data from joint registries are not reflecting the frequency of PJI and can be misleading; particularly low-grade PJI can be frequently misdiagnosed as aseptic failure.
Microbiological analysis of sonicate has in comparison with joint aspirate significantly higher sensitivity and specificity, which allows better detection of low grade infection. With aspiration only free-floating, high metabolically active, planktonic form of bacteria could be collected. Contrarily, the less metabolically active bacteria are hidden under the biofilm can remain undetected.
Sonication of prosthetic material mechanically dislodge the biofilm from surface and expose the sessile bacteria for the microbiological analysis.
All foreign materials provoke biofilm formation however, different materials showed different resistance for biofilm adhesion.
In this study patients with PJI are undergoing standard one- or two- stage revision procedure of the hip. The removed bearing components will be sonicated and sent in microbiological analysis. The ceramic, metal and polyethylene prosthesis components will undergo qualitative and quantitative microbiological analysis. The materials will be compared regarding to the presence of biofilm formation.
- Conditions
- Sonication, Total Hip Replacement, Biofilm
- Being tested
- Sonication, Microbiological analysis
- Keywords
- biofilm, periprosthetic joint infection, hip, endoprothesis, ceramic, bearing components, sonication, low grade infection, joint aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SonicationOther
Ultrasound bath (40 kHz, 1 W/cm2, 1 min) of bearing components of the prosthesis in sterile conditions.
Microbiological analysisOther
Plating the sonicates on agar plates.
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative analysis of sonication fluid after sonication of explanted bearing components of the hip endoprosthesis during a revision surgery
Qualitative Analysis, i.e. frequency of positive sonication fluid cultures (No. positive/No. all cultures) deriving from 3 different biomaterials (namely: Ceramic, Cobalt-chrome-metal, and Polyethylene), the number of variables which will be evaluated following: bearing component and its material (Ceramic, Cobalt-chrome-metal, and Polyethylene).
All three material types will be compared between each other regard to microbiology analysis of sonication fluid of bearing components.
Measured: Prospective: patient recruitment up to 2 years
Quantitative Analysis e.g. No. of microorganisms in sonication fluid (CFU/ml) deriving from 3 different biomaterials (namely: Ceramic, Cobalt-chrome-metal, and Polyethylene).
Measured: Prospective: patient recruitment up to 2 years
Secondary outcomes (1)
Amount of patients with septic loosening of hip joint
Measured: Prospective: patient recruitment up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study startJun 2014
- Primary completionDec 2016 (estimated)
- Study completionMar 2017 (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 SonicationStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Ceram Tec GmbH, Pro-Implant Foundation
- Responsible party
- Principal investigator, Andrej Trampuz, Charite University, Berlin, Germany
- Investigators
- Andrej Trampuz, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02853461
- Sponsor's protocol ID
- Endo 015/15
- Status last verified
- Aug 2016
- First submitted
- 20 Jul 2016
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Achermann Y, Vogt M, Leunig M, Wust J, Trampuz A. Improved diagnosis of periprosthetic joint infection by multiplex PCR of sonication fluid from removed implants. J Clin Microbiol. 2010 Apr;48(4):1208-14. doi: 10.1128/JCM.00006-10. Epub 2010 Feb 17.
PubMed 20164283Banche G, Allizond V, Bracco P, Bistolfi A, Boffano M, Cimino A, Brach del Prever EM, Cuffini AM. Interplay between surface properties of standard, vitamin E blended and oxidised ultra high molecular weight polyethylene used in total joint replacement and adhesion of Staphylococcus aureus and Escherichia coli. Bone Joint J. 2014 Apr;96-B(4):497-501. doi: 10.1302/0301-620X.96B4.32895.
PubMed 24692617Gomez-Barrena E, Esteban J, Medel F, Molina-Manso D, Ortiz-Perez A, Cordero-Ampuero J, Puertolas JA. Bacterial adherence to separated modular components in joint prosthesis: a clinical study. J Orthop Res. 2012 Oct;30(10):1634-9. doi: 10.1002/jor.22114. Epub 2012 Mar 30.
PubMed 22467526
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biofilm Investigation on Ceramic, Metal and Polyethylene Bearing Components From Explanted Hip Joint Prosthesis
- ClinicalTrials.gov ID
- NCT02853461
- Acronym / sponsor ID
- Endo 015/15
- Conditions
- Sonication, Total Hip Replacement, Biofilm
- Keywords
- biofilm, periprosthetic joint infection, hip, endoprothesis, ceramic, bearing components, sonication, low grade infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Ceram Tec GmbH, Pro-Implant Foundation
- Study start
- Jun 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 3 Aug 2016 (estimated)
- 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.
In this study the investigators sonicate the bearing components of the explanted hip prosthesis which allows highly sensitive detection of in vivo biofilms (qualitatively and quantitatively). The hip prosthesis bearing components are composed from different material. The purpose of this study is to analyse the resistance against biofilm adhesion of ceramic, metal and polyethylene prosthesis components through microbiologic analysis of sonicates.
Detailed description
The main reasons for hip prosthesis failure are aseptic loosening and periprosthetic joint infection (PJI). The real frequency of PJI is probably largely underestimated because of non-standardized definition criteria, diagnostic procedure, treatment algorithm and other confounders. Therefore, data from joint registries are not reflecting the frequency of PJI and can be misleading; particularly low-grade PJI can be frequently misdiagnosed as aseptic failure.
Microbiological analysis of sonicate has in comparison with joint aspirate significantly higher sensitivity and specificity, which allows better detection of low grade infection. With aspiration only free-floating, high metabolically active, planktonic form of bacteria could be collected. Contrarily, the less metabolically active bacteria are hidden under the biofilm can remain undetected.
Sonication of prosthetic material mechanically dislodge the biofilm from surface and expose the sessile bacteria for the microbiological analysis.
All foreign materials provoke biofilm formation however, different materials showed different resistance for biofilm adhesion.
In this study patients with PJI are undergoing standard one- or two- stage revision procedure of the hip. The removed bearing components will be sonicated and sent in microbiological analysis. The ceramic, metal and polyethylene prosthesis components will undergo qualitative and quantitative microbiological analysis. The materials will be compared regarding to the presence of biofilm formation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients ≥18 y, undergoing hip prosthesis explantation for infection or mechanical (aseptic) reason.
Key inclusion criteria (3 listed)
- Subject must be aged 18 or more.
- Subject must be scheduled to undergo an explanation of the hip endoprosthesis during the 1- or 2- stage revision procedure because of the septic or mechanical indication.
- Subject must personally sign and date the informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
Key exclusion criteria (1 listed)
- Patient not scheduled for the index Operation procedure with removal of hip endoprosthesis
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 |
|---|---|---|
| SonicationUltrasound bath (40 kHz, 1 W/cm2, 1 min) of bearing components of the prosthesis in sterile conditions. | Other | – |
| Microbiological analysisPlating the sonicates on agar plates. | Other | – |
Primary outcome
Qualitative analysis of sonication fluid after sonication of explanted bearing components of the hip endoprosthesis during a revision surgery
Time frame: Prospective: patient recruitment up to 2 years
Qualitative Analysis, i.e. frequency of positive sonication fluid cultures (No. positive/No. all cultures) deriving from 3 different biomaterials (namely: Ceramic, Cobalt-chrome-metal, and Polyethylene), the number of variables which will be evaluated following: bearing component and its material (Ceramic, Cobalt-chrome-metal, and Polyethylene). All three material types will be compared between each other regard to microbiology analysis of sonication fluid of bearing components.
Quantitative Analysis e.g. No. of microorganisms in sonication fluid (CFU/ml) deriving from 3 different biomaterials (namely: Ceramic, Cobalt-chrome-metal, and Polyethylene).
Time frame: Prospective: patient recruitment up to 2 years
1 secondary outcome
Amount of patients with septic loosening of hip joint
Time frame: Prospective: patient recruitment up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2016.
- Background: PubMed 20164283Achermann Y, Vogt M, Leunig M, Wust J, Trampuz A. Improved diagnosis of periprosthetic joint infection by multiplex PCR of sonication fluid from removed implants. J Clin Microbiol. 2010 Apr;48(4):1208-14. doi: 10.1128/JCM.00006-10. Epub 2010 Feb 17.
- Background: PubMed 24692617Banche G, Allizond V, Bracco P, Bistolfi A, Boffano M, Cimino A, Brach del Prever EM, Cuffini AM. Interplay between surface properties of standard, vitamin E blended and oxidised ultra high molecular weight polyethylene used in total joint replacement and adhesion of Staphylococcus aureus and Escherichia coli. Bone Joint J. 2014 Apr;96-B(4):497-501. doi: 10.1302/0301-620X.96B4.32895.
- Background: PubMed 22467526Gomez-Barrena E, Esteban J, Medel F, Molina-Manso D, Ortiz-Perez A, Cordero-Ampuero J, Puertolas JA. Bacterial adherence to separated modular components in joint prosthesis: a clinical study. J Orthop Res. 2012 Oct;30(10):1634-9. doi: 10.1002/jor.22114. Epub 2012 Mar 30.
- Individual participant dataSharing planned: Yes
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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.
Andrej Trampuz, MD principal investigator
Charite University, Berlin, Germany
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 Sonication and Total Hip Replacement, run by Charite University, Berlin, Germany at 1 site in Germany.
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 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: status not confirmed, as of the sponsor's last update on 4 Aug 2016. 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 Germany. 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 Andrej Trampuz, MD (+49 30 450 615 073, andrej.trampuz@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative analysis of sonication fluid after sonication of explanted bearing components of the hip endoprosthesis during a revision surgery (time frame: Prospective: patient recruitment up to 2 years). The study lists 2 primary outcomes in all. 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 NCT02853461, 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 4 Aug 2016.