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Heraeus MicroDTTect Lyon Pilot Studyprosthetic Joint Infections (PJIs)

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04371068
Enrollment
20
Registered
2020-05-01
Start date
2018-03-01
Completion date
2019-09-01
Last updated
2020-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic PJIs

Keywords

bone and joint infection, biofilm, joint arthroplasty, implant failure, prosthetic joint infection, dithiothreitol

Brief summary

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

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.

Interventions

BIOLOGICALCulture of removed prosthesis using DTT

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).

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of bacteria isolated isolatedevery day until 15 days of culturetype of bacteria isolated

Secondary

MeasureTime frameDescription
time to positivity of culturesevery day until 15 days of culturetime to positivity of cultures of the fluid obtained after prosthesis treatment using the MicroDTTect system in comparison with conventional culture of PPT samples

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026