Biofilm Investigation on Bearing Components of Explanted Hip Joint Prosthesis
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|ClinicalTrials.gov Identifier: NCT02853461|
Recruitment Status : Recruiting
First Posted : August 3, 2016
Last Update Posted : August 4, 2016
|Condition or disease||Intervention/treatment|
|Sonication Total Hip Replacement Biofilm||Other: Sonication Other: Microbiological analysis|
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 Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Biofilm Investigation on Ceramic, Metal and Polyethylene Bearing Components From Explanted Hip Joint Prosthesis|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||March 2017|
- Other: Sonication
Ultrasound bath (40 kHz, 1 W/cm2, 1 min) of bearing components of the prosthesis in sterile conditions.
- Other: Microbiological analysis
Plating the sonicates on agar plates.
- 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 ]
- Amount of patients with septic loosening of hip joint [ Time Frame: Prospective: patient recruitment up to 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02853461
|Contact: Andrej Trampuz, MD||+49 30 450 615 email@example.com|
|Charité Universitätsmedizin Berlin||Recruiting|
|Berlin, Germany, 10117|
|Contact: Andrej Trampuz, MD +49 30 450 615 073 firstname.lastname@example.org|
|Principal Investigator:||Andrej Trampuz, MD||Charite University, Berlin, Germany|