Heraeus MicroDTTect Lyon Pilot Studyprosthetic Joint Infections (PJIs)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-01

Study Completion Date

2019-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Prosthesis Infection and One-step Exchange: Pretreatment by Targeted Antibiotic Therapy in At-risk Patients

NCT03848091

Prosthetic Joint Infection Antibiotic Resistant Infection

COMPLETED

Microbiological Epidemiology in Patients Experiencing Microbiological or Clinical Failure Following Reimplantation After a 2-stage Exchange Strategy for Hip or Knee Prosthetic Joint Infection

NCT03627000

Bone and Joint Infection Bacterial Infections EPIDEMIOLOGY

COMPLETED

Treatment of Acute Periprosthetic Joint Infection Comparing Single and Planned Double-Debridement Antibiotics and Implant Retention Followed by Chronic Antibiotic Suppression

NCT05640336

Periprosthetic Joint Infection

ENROLLING_BY_INVITATION NA

Cohort of Prosthetic Joint Infections

NCT02801253

Prosthetic Joint Infection

RECRUITING

Bacteriological Setting Before Prosthesis Implantation With One Stage Surgery in Prosthetic Joint Infection

NCT02806063

Prosthetic Joint Infection

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic PJIs

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Culture of removed prosthesis using DTT

Intervention Type BIOLOGICAL

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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Culture 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).

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No