Biofilm Clinical Trial - Biofilm Investigation on Bearing Components of

Status Recruiting

Clinical 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. 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02853461
Study type	Observational
Source	Charite University, Berlin, Germany
Contact	Andrej Trampuz, MD
Phone	+49 30 450 615 073
Email	andrej.trampuz@charite.de
Status	Recruiting
Phase	N/A
Start date	June 2014
Completion date	March 2017

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Biofilm Investigation on Bearing Components of Explanted Hip Joint Prosthesis

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms