Heraeus MicroDTTect Lyon Pilot Studyprosthetic Joint Infections (PJIs)

Study Overview
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Brief Summary
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Prosthetic joint infections (PJIs) are one of the main causes of implant failure after joint arthroplasty. Identification of the causal organism is crucial for successful treatment. However, microbiological diagnosis of PJIs remains a challenge notably because bacteria are embedded in biofilm adhered to the material. Recently, dithiothreitol (DTT) treatment of prosthesis has been proposed as a new strategy to dislodge bacteria from biofilm, thus becoming an alternative to sonication to improve the yield of the microbiological diagnosis. In this study, the investigators evaluate the interest of a commercial device using DTT, the MicroDTTect system (Heraeus, Hanau, Allemagne), for the diagnosis of low-grade chronic PJIs compared to the conventional culture of periprosthetic tissue (PPT) samples.

Detailed Description
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Prosthetic joint infections (PJIs) are one of the main causes of implant failure after joint arthroplasty. Identification of the causal organism is crucial for successful treatment. However, microbiological diagnosis of PJIs remains a challenge notably because bacteria are embedded in biofilm adhered to the material. Recently, dithiothreitol (DTT) treatment of prosthesis has been proposed as a new strategy to dislodge bacteria from biofilm, thus becoming an alternative to sonication to improve the yield of the microbiological diagnosis. In this study, the investigators evaluate the interest of a commercial device using DTT, the MicroDTTect system (Heraeus, Hanau, Allemagne), for the diagnosis of low-grade chronic PJIs compared to the conventional culture of periprosthetic tissue (PPT) samples.

Official Title
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Evaluation of the microDTTect Device (Heraeus) in the Diagnosis of Low-grade Chronic

Conditions
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Chronic PJIs

Intervention / Treatment
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* Biological: Culture of removed prosthesis using DTT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients with painful prosthesis or prosthesis loosening <10 years without mechanical explanation, without clinical evidence of infection (no fistula, no abscess, no discharge, no local inflammation), without microbiological diagnosis (absence of preoperative joint puncture (not performed or not feasible) or with a culture-negative preoperative joint puncture). Exclusion Criteria: Patients with painful prosthesis or prosthesis loosening with mechanical explanation, or with clinical evidence of infection (fistula, abscess, discharge, local inflammation), with a previous microbiological diagnosis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients suspected of low-grade PJIs<br>Adult patients suspected of low-grade PJIs, who have a scheduled prosthesis removal or change and who meet the inclusion criteria | Biological: Culture of removed prosthesis using DTT<br>* No specific or supplementary intervention is performed among patients. The included patients have scheduled surgery consisting of prosthesis removal or change. Instead of being discarded, the prosthesis which was removed during the surgery was sent to the laboratory using the MicroDTTect system and bacterial culture was performed with the fluid obtained. Results will be then compared to classical culture of periprosthetic tissues (PPT).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of bacteria isolated isolated | type of bacteria isolated | every day until 15 days of culture | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to positivity of cultures | time to positivity of cultures of the fluid obtained after prosthesis treatment using the MicroDTTect system in comparison with conventional culture of PPT samples | every day until 15 days of culture | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bone and joint infection, biofilm, joint arthroplasty, implant failure, prosthetic joint infection, dithiothreitol