ClinicalTrials.gov
ClinicalTrials.gov Menu

Biofilm Investigation on Bearing Components of Explanted Hip Joint Prosthesis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02853461
Recruitment Status : Recruiting
First Posted : August 3, 2016
Last Update Posted : August 4, 2016
Sponsor:
Collaborators:
Ceram Tec GmbH
Pro-Implant Foundation
Information provided by (Responsible Party):
Andrej Trampuz, Charite University, Berlin, Germany

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.

Condition or disease Intervention/treatment
Sonication Total Hip Replacement Biofilm Other: Sonication Other: Microbiological analysis

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 Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Intervention Details:
  • 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.


Primary Outcome Measures :
  1. 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.


  2. 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 ]

Secondary Outcome Measures :
  1. Amount of patients with septic loosening of hip joint [ Time Frame: Prospective: patient recruitment up to 2 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients ≥18 y, undergoing hip prosthesis explantation for infection or mechanical (aseptic) reason.
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

Information from the National Library of Medicine

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


Contacts
Contact: Andrej Trampuz, MD +49 30 450 615 073 andrej.trampuz@charite.de

Locations
Germany
Charité Universitätsmedizin Berlin Recruiting
Berlin, Germany, 10117
Contact: Andrej Trampuz, MD    +49 30 450 615 073    andrej.trampuz@charite.de   
Sponsors and Collaborators
Charite University, Berlin, Germany
Ceram Tec GmbH
Pro-Implant Foundation
Investigators
Principal Investigator: Andrej Trampuz, MD Charite University, Berlin, Germany

Publications:
Responsible Party: Andrej Trampuz, MD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02853461     History of Changes
Other Study ID Numbers: Endo 015/15
First Posted: August 3, 2016    Key Record Dates
Last Update Posted: August 4, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Andrej Trampuz, Charite University, Berlin, Germany:
biofilm
periprosthetic joint infection
hip
endoprothesis
ceramic
bearing components
sonication
low grade infection
joint aspiration