Biofilm Investigation on Bearing Components of Explanted Hip Joint Prosthesis

NCT02853461 | Unknown DMC

• 1 other identifier: Endo 015/15
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Sonication; Total Hip Replacement; Biofilm

Keywords

biofilm; periprosthetic joint infection; hip; endoprothesis; ceramic; bearing components; sonication; low grade infection; joint aspiration

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (1)

• Amount of patients with septic loosening of hip joint

  Prospective: patient recruitment up to 2 years

Interventions

Sonication OTHER

Ultrasound bath (40 kHz, 1 W/cm2, 1 min) of bearing components of the prosthesis in sterile conditions.

Microbiological analysis OTHER

Plating the sonicates on agar plates.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients ≥18 y, undergoing hip prosthesis explantation for infection or mechanical (aseptic) reason.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Ceram Tec GmbH: collaborator
• Pro-Implant Foundation: collaborator

Study Sites (1)

Charité Universitätsmedizin Berlin

Berlin, State of Berlin, 10117, Germany

RECRUITING

Related Publications (3)

• 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.

  PMID: 20164283 BACKGROUND

• 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.

  PMID: 24692617 BACKGROUND

• 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.

  PMID: 22467526 BACKGROUND

MeSH Terms

Interventions

Sonication

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Andrej Trampuz, MD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrej Trampuz, MD

CONTACT

+49 30 450 615 073; andrej.trampuz@charite.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 20, 2016
• First Posted: August 3, 2016
• Study Start: June 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: August 4, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)