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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02598141
Acronym
IOAP Turrax
Enrollment
122
Registered
2015-11-05
Start date
2016-05-18
Completion date
2018-11-21
Last updated
2026-02-02

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

Conditions

Bacterial Infection

Keywords

Protheses, nails, screws or plates

Brief summary

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

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.

Interventions

BIOLOGICALBiological 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.

BIOLOGICALBiological 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.

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

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

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

Design outcomes

Primary

MeasureTime frame
Presence/absence of an osteo-articular infection according to sample that underwent Ultra Turrax® grindingBaseline
Presence/absence of an osteo-articular infection according to sample that underwent standard treatmentBaseline

Secondary

MeasureTime frame
Identification of bacterial speciesBaseline

Countries

France

Contacts

PRINCIPAL_INVESTIGATORNicolas Cellier, MD

Centre Hospitalier Universitaire de Nîmes

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026