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

Study Overview
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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.

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.

Official Title
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Comparative Evaluation of Two Techniques for the Treatment of Per-operative Bacteriological Samples Associated With Osteo-articular Sepsis: Grinding (Ultra Turrax) Versus Standard Methods

Conditions
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Bacterial Infection

Intervention / Treatment
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* Biological: Biological sampling grinding
* Biological: Biological sampling with standard procedures


Participation Criteria
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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

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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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Per-op biopsy around material<br>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 | Biological: Biological sampling grinding<br>* 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.<br>Biological: Biological sampling with standard procedures<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence/absence of an osteo-articular infection according to sample that underwent Ultra Turrax® grinding |  | Baseline | 
| Presence/absence of an osteo-articular infection according to sample that underwent standard treatment |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of bacterial species |  | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Protheses, nails, screws or plates