Sonication of removed hip and knee prosthesis 2017
Research type
Research Study
Full title
Sonication of removed hip and knee prosthesis for the diagnosis of prosthetic joint infection-A Feasibility Study.
IRAS ID
206909
Contact name
Matthew Wilson
Contact email
Sponsor organisation
Royal Devon & Exeter NHS Foundation Trust
Duration of Study in the UK
1 years, 7 months, 3 days
Research summary
Prosthetic joint infections are often difficult to distinguish from aseptic loosening on clinical grounds. Microbiological results of tissue biopsies, inflammatory markers, clinical picture and operative findings are used to make the diagnosis. It is our routine practice to take five intra-operative tissue samples and synovial fluid to try and increase the likelihood of detecting a pathogen. All these samples need to be processed and patients are initiated on broad-spectrum antibiotics until culture results are back, which may take up to five days. However, microbiological testing of tissue samples is neither sensitive nor specific with high rates of contaminating organisms and failure to isolate the true organism.
Sonication has emerged as a practical and effective method to dislodge bacteria from the surface of the implant, possibly improving detection rates and speeding diagnosis.
Therefore, in addition to standard processing of tissue samples, we propose to perform sonication on the removed implants. We would like to conduct a feasibility study looking at the use of sonication as a diagnostic tool for identifying organisms present on removed hip and knee prosthesis. By dislodging micro-organisms from biofilms the sensitivity and specificity of their detection will markedly improve as well as providing a result more quickly. The potential benefits of this are to allow earlier initiation of the correct antibiotic regime, as well as reducing costs and length of hospital stay.
The target recruitment is 50 patients, 25 consecutive patients undergoing revision hip arthroplasty for any reason and 25 undergoing revision knee arthroplasty for any reason. Patients will be identified at pre-operative assessment clinics or on the ward, if in-patients, and approached initially by the surgeon and then research nurses who will provide information and, where appropriate, take consent for participation. All samples for sonication will be anonymised and routine treatment will not be affected.REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
17/YH/0159
Date of REC Opinion
1 Jun 2017
REC opinion
Further Information Favourable Opinion