Biofilm Investigation on Bearing Components of Explanted Hip Joint Prosthesis

Total Hip Replacement Clinical Trial

Official title:

Biofilm Investigation on Ceramic, Metal and Polyethylene Bearing Components From Explanted Hip Joint Prosthesis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02853461
• Other study ID #: Endo 015/15
• Status: Recruiting
• Phase: N/A
• First received: July 20, 2016
• Last updated: August 3, 2016
• Start date: June 2014
• Est. completion date: March 2017

Study information

• Verified date: August 2016
• Source: Charite University, Berlin, Germany
• Contact: Andrej Trampuz, MD
• Phone: +49 30 450 615 073
• Email: andrej.trampuz[@]charite.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Biofilm
• Sonication
• Total Hip Replacement

Intervention

Other:
• Sonication
Ultrasound bath (40 kHz, 1 W/cm2, 1 min) of bearing components of the prosthesis in sterile conditions.
• Microbiological analysis
Plating the sonicates on agar plates.

Locations

Country	Name	City	State
Germany	Charité Universitätsmedizin Berlin	Berlin

Sponsors (3)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Ceram Tec GmbH, Pro-Implant Foundation

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Achermann Y, Vogt M, Leunig M, Wüst 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. — View 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. — View Citation

Gómez-Barrena E, Esteban J, Medel F, Molina-Manso D, Ortiz-Pérez A, Cordero-Ampuero J, Puértolas 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Prospective: patient recruitment up to 2 years	No
Primary	Quantitative Analysis e.g. No. of microorganisms in sonication fluid (CFU/ml) deriving from 3 different biomaterials (namely: Ceramic, Cobalt-chrome-metal, and Polyethylene).		Prospective: patient recruitment up to 2 years	No
Secondary	Amount of patients with septic loosening of hip joint		Prospective: patient recruitment up to 2 years	No