Clinical trial NCT02853461: Biofilm Investigation on Bearing Components of Explanted Hip Joint Prosthesis
Official title: Biofilm Investigation on Ceramic, Metal and Polyethylene Bearing Components From Explanted Hip Joint Prosthesis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sonication
Total Hip Replacement
Biofilm
Keywords: biofilm
periprosthetic joint infection
hip
endoprothesis
ceramic
bearing components
sonication
low grade infection
joint aspiration
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Ceram Tec GmbH
name: Pro-Implant Foundation
First posted: 2016-08-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients ≥18 y, undergoing hip prosthesis explantation for infection or mechanical (aseptic) reason.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Patient not scheduled for the index Operation procedure with removal of hip endoprosthesis

Primary outcomes:
measure: Qualitative analysis of sonication fluid after sonication of explanted bearing components of the hip endoprosthesis during a revision surgery
timeFrame: Prospective: patient recruitment up to 2 years
measure: Quantitative Analysis e.g. No. of microorganisms in sonication fluid (CFU/ml) deriving from 3 different biomaterials (namely: Ceramic, Cobalt-chrome-metal, and Polyethylene).
timeFrame: Prospective: patient recruitment up to 2 years
Secondary outcomes:
measure: Amount of patients with septic loosening of hip joint
timeFrame: Prospective: patient recruitment up to 2 years
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Andrej Trampuz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Banche 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.
citation: Gomez-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.