NCT02598141

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 5, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

May 18, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2018

Completed
Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

2.5 years

First QC Date

November 4, 2015

Last Update Submit

January 29, 2026

Conditions

Bacterial Infection

Keywords

Protheses, nails, screws or plates

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Identification of bacterial species

    Baseline

Study Arms (1)

Per-op biopsy around material

OTHER

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 grindingBiological: Biological sampling with standard procedures

Interventions

Biological sampling grindingBIOLOGICAL

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.

Per-op biopsy around material
Biological sampling with standard proceduresBIOLOGICAL

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.

Per-op biopsy around material

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • The patient is participating in another 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

Related Publications (1)

  • Brunaud M, Boutet-Dubois A, Pantel A, Salipante F, Coulomb R, Sotto A, Lavigne JP, Cellier N. Improved Microbiological Diagnosis of Bone and Joint Infections Using Mechanical Bead-Milling Extraction of Bone Specimens with the Ultra-Turrax(R) System. Diagnostics (Basel). 2026 Jan 18;16(2):309. doi: 10.3390/diagnostics16020309.

    PMID: 41594285RESULT

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Study Officials

  • Nicolas Cellier, MD

    Centre Hospitalier Universitaire de Nîmes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2015

First Posted

November 5, 2015

Study Start

May 18, 2016

Primary Completion

November 21, 2018

Study Completion

November 21, 2018

Last Updated

February 2, 2026

Record last verified: 2026-01

Locations

FR(1)