Bacterial InfectionIOAP TurraxNCT02598141
Grinding Versus Standard Methods for the Treatment of Per-operative Bacteriological Samples Associated With Osteo-articular Sepsis
A study testing Biological sampling grinding and Biological sampling with standard procedures in people with Bacterial Infection, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacterial Infection
- What is being tested?
- Biological sampling grinding and Biological sampling with standard procedures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteFrance
- Study dates
- 18 May 2016to 21 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of Two Techniques for the Treatment of Per-operative Bacteriological Samples Associated With Osteo-articular Sepsis: Grinding (Ultra Turrax) Versus Standard Methods
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.
Read the detailed description
The secondary objectives of this study are to:
- Compare the two techniques in terms of bacterial species identified.
- 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).
- Compare the diagnostic capabilities (sensitivity and specificity) of the two sample processing techniques depending on the type of joint (subgroup analysis).
- 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).
- Develop a culture collection of bacteria isolated from infection osteo-articular protheses.
- Conditions
- Bacterial Infection
- Being tested
- Biological sampling grinding, Biological sampling with standard procedures
- Keywords
- Protheses, nails, screws or plates
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: Biological sampling grinding; Biological: Biological sampling with standard procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence/absence of an osteo-articular infection according to sample that underwent Ultra Turrax® grinding
Measured: Baseline
Presence/absence of an osteo-articular infection according to sample that underwent standard treatment
Measured: Baseline
Secondary outcomes (1)
Identification of bacterial species
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study start18 May 2016
- Primary completion21 Nov 2018
- Study completion21 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bacterial InfectionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Cellier, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02598141
- Sponsor's protocol ID
- LOCAL/2015/NC-01
- Other IDs
- 2015-A00720-49
- Acronym
- IOAP Turrax
- Status last verified
- Jan 2026
- First submitted
- 4 Nov 2015
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 41594285
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Two Techniques for the Treatment of Per-operative Bacteriological Samples Associated With Osteo-articular Sepsis: Grinding (Ultra Turrax) Versus Standard Methods
- ClinicalTrials.gov ID
- NCT02598141
- Acronym / sponsor ID
- IOAP Turrax / LOCAL/2015/NC-01
- Conditions
- Bacterial Infection
- Keywords
- Protheses, nails, screws or plates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 18 May 2016 (actual)
- Primary completion
- 21 Nov 2018 (actual)
- Study completion
- 21 Nov 2018 (actual)
- First posted
- 5 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Compare the two techniques in terms of bacterial species identified.
- 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).
- Compare the diagnostic capabilities (sensitivity and specificity) of the two sample processing techniques depending on the type of joint (subgroup analysis).
- 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).
- Develop a culture collection of bacteria isolated from infection osteo-articular protheses.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Per-op biopsy around material | Other | Biological: Biological sampling grinding, Biological: Biological sampling with standard proceduresPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological sampling grindingOne 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 | Per-op biopsy around material |
| Biological sampling with standard proceduresOne half of the biological material collected during the intervetion (according to standard procedures) will be treated according to standard techniques before proceeding with culturing. | Biological | Per-op biopsy around material |
Primary outcome
Presence/absence of an osteo-articular infection according to sample that underwent Ultra Turrax® grinding
Time frame: Baseline
Presence/absence of an osteo-articular infection according to sample that underwent standard treatment
Time frame: Baseline
1 secondary outcome
Identification of bacterial species
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Results publication: PubMed 41594285Brunaud 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Cellier, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological sampling grinding and Biological sampling with standard procedures in people with Bacterial Infection, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence/absence of an osteo-articular infection according to sample that underwent Ultra Turrax® grinding (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02598141, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.