Grinding Versus Standard Methods for the Treatment of Per-operative Bacteriological Samples Associated With Osteo-articular Sepsis

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-18

Study Completion Date

2018-11-21

Brief Summary

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The main objective of this study was to compare the diagnostic capability (sensitivity and specificity) of standard bacteriological analysis made from one or other of the two sampling processing techniques and perioperative management of samples : the Ultra Turrax method that uses grinding versus the standard method.

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Detailed Description

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The secondary objectives of this study are to:

A. Compare the two techniques in terms of bacterial species identified.

B. Compare the diagnostic capabilities (sensitivity and specificity) of the two sample processing techniques depending on the type of analyzed samples (soft tissue, bone tissue) (subgroup analysis).

C. Compare the diagnostic capabilities (sensitivity and specificity) of the two sample processing techniques depending on the type of joint (subgroup analysis).

D. Compare the diagnostic capabilities (sensitivity and specificity) of the two sample processing techniques depending on the type of implanted materials (prosthesis versus other equipment) (subgroup analysis).

E. Develop a culture collection of bacteria isolated from infection osteo-articular protheses.

Conditions

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Bacterial Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Per-op biopsy around material

Patients included in this study require biopsies for suspicion of infected osteo-articular materials (implants, protheses, nails, screw, plates).

Interventions:

* Biological sampling grinding
* Biological sampling with standard procedures

Group Type OTHER

Biological sampling grinding

Intervention Type BIOLOGICAL

One half of the biological material collected during the intervetion (according to standard procedures) will be ground using the Ultra Turrax technique before proceeding with culturing.

Biological sampling with standard procedures

Intervention Type BIOLOGICAL

One half of the biological material collected during the intervetion (according to standard procedures) will be treated according to standard techniques before proceeding with culturing.

Interventions

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Biological sampling grinding

One half of the biological material collected during the intervetion (according to standard procedures) will be ground using the Ultra Turrax technique before proceeding with culturing.

Intervention Type BIOLOGICAL

Biological sampling with standard procedures

One half of the biological material collected during the intervetion (according to standard procedures) will be treated according to standard techniques before proceeding with culturing.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* The patient must be insured or beneficiary of a health insurance plan
* The patient is cared for in the operating theater because of a suspicion of an osteo-articular infection involving any type of material (protheses, screws, plates) and requiring bacteriological sampling
* The patient has not taken any antibiotics within the past 15 days

Exclusion Criteria

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection
* It is impossible to correctly inform the patient
* The patient is pregnant, parturient, or breastfeeding
* The subject presents with an osteo-articulaire infection without material
* Systematic samplings from reversals of aseptic prostheses
* Second intervention for the same patient

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No