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CompletedNCT04371068Updated May 1, 2020

Heraeus MicroDTTect Lyon Pilot Studyprosthetic Joint Infections (PJIs)

An observational study in Chronic PJIs, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-01.

Sponsored by Hospices Civils de Lyon · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Chronic PJIs

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Keywords

  • bone and joint infection
  • biofilm
  • joint arthroplasty
  • implant failure
  • prosthetic joint infection
  • dithiothreitol
03

In context

Infections

6,686 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 20 is below the median of 240 across 2,136 observational studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients with painful prosthesis or prosthesis loosening \<10 years treated at the CRIOAc Lyon

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

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
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
20 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients suspected of low-grade PJIs

    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

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).

06

What researchers measure

Primary outcomes

  1. Rate of bacteria isolated isolated

    type of bacteria isolated

    Time frame: every day until 15 days of culture

Secondary outcomes

  1. 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

    Time frame: every day until 15 days of culture

07

Study locations

1 site
  • Hospices Civils de Lyon
    Lyon, 69004, France
08

References and documents

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04371068
Lead sponsor
Hospices Civils de Lyon
Responsible party
Eugénie MABRUT (clinical research assistant, Hospices Civils de Lyon) — Principal investigator
First posted
May 1, 2020
Start date
Mar 1, 2018
Primary completion
Sep 1, 2019
Completion
Sep 1, 2019
Last update
May 1, 2020

Study contacts

FREDERIC LAURENT
principal investigator · LAURENT

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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