Septic ArthritisSEPT'ECHONCT02018952
Ultrasonography Assessment of Septic Arthritis on Native Joint
A study testing Ultrasonography assessment in people with Septic Arthritis, run by Nantes University Hospital at 3 sites in France.
Trial summary
The aim of this trial is to study the interest of ultrasonography among patients with septic arthritis. Currently, ultrasonography is useful for detecting small fluid effusions, for examining otherwise inaccessible joints, such as the hip and for helping the joint aspiration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Arthritis
- What is being tested?
- Ultrasonography assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 3 sitesFrance
- Study dates
- Jan 2014to Jul 2015
- 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
- Major patients hospitalized in Rheumatology, Infectiology, Orthopedy Department (hospital of Nantes, of La Roche sur Yon and of Saint-Nazaire) with a septic arthritis of shoulder, or elbow, or wrist , or hip, or knee, or ankle on native joint, with positive microbiologic culture joint fluid or positive hemoculture; the diagnosis was based on positive histology or imagery with an inflammatory joint fluid if the microbiologic cultures (hemoculture or joint effusion) were negative.
Who cannot join
- Presence of material on the targeted joint
- Age < 18 years old
- Patients under guardianship
- Pregnancy
Trial locations and contacts
3 sites in 1 country.
France3 sites
CH La Roche-sur-Yon
La Roche-sur-Yon, 85000
CH de Nantes
Nantes, 44093
CH Saint-Nazaire
Saint-Nazaire, 44600
About this study
Official title: Ultrasonography Assessment of Septic Arthritis on Native Joint: a Descriptive, Exploratory, Prospective, Multicentric Trial
The aim of this trial is to study the interest of ultrasonography among patients with septic arthritis.
Currently, ultrasonography is useful for detecting small fluid effusions, for examining otherwise inaccessible joints, such as the hip and for helping the joint aspiration.
Read more
Accurate assessment of disease activity and joint damage in septic arthritis is important for monitoring treatment efficiency and for prediction of the outcome of the disease.
Nowadays, magnetic resonance imaging (MRI) provides better resolution than radiography or tomography for the detection of joint effusion and for differentiation between bone and soft tissue infectious. The sensibility is reported to be nearly 100% with a specificity of more than 75%.
However, MRI is expensive and not rapidly accessible.
Therefore, ultrasonography, a non invasive, painless, inexpensive, and non radiating exam can be used to assess the presence and extent of inflammation, destruction, and tissue response.
The objective is to describe, using ultrasonography, the abnormalities joint structure influenced the septic arthritis evolution and prognosis.
The investigators hope, at the end of this study, to evaluate ultrasonography interest in septic arthritis and to establish ultrasonography prognosis factors to predict treatment efficiency and functional outcome.
- Conditions
- Septic Arthritis
- Being tested
- Ultrasonography assessment
- Keywords
- Septic arthritis, Ultrasonography, Prognosis parameters
- Medical subject headings
- Arthritis, Infectious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonography assessmentOther
All patients will be seen at day 0, day 4, day 15 and at 3 months. These visits are usually programmed. Only monitoring ultrasonography, a non invasive exam, and self-administered questionnaires will be made, additional to standard exams for all patients included (no control group).
Day 0 :
- Information of patient and no opposition getting
- Clinical exam
- Laboratory tests
- Radiography of the targeted joint
- Ultrasonography of the targeted joint and controlateral joint (about 20 minutes)
Day 4 :
- Clinical exam
- Laboratory tests
- Ultrasonography of the targeted joint and controlateral joint (about 20 minutes)
Day15 :
- Clinical exam
- Laboratory tests
- Ultrasonography of the targeted joint and controlateral joint (about 20 minutes)
M3 :
- Clinical exam
- Laboratory tests
- Radiography of the targeted joint
- Ultrasonography of the targeted joint and controlateral joint (about 20 minutes)
- Functional outcome
| Study group | Role | What they receive |
|---|---|---|
| Ultrasonography assessment | Other | Not described Receives: Other: Ultrasonography assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abnormalities joint structure influencing the septic arthritis evolution and prognosis
Ultrasonography description of :
- synovium aspect : homogeneous, nodular
- maximum thickness synovium
- synovium doppler signal (grade 0, 1, 2, 3)
- presence and aspect of joint effusion : anechoic, hypo/hyperechoic, heterogeneous
- presence and aspect of bone erosions : single, minimal/deep, multiple, minimal/ deep
- presence of a synovium partitioning
- soft tissue aspect : cellulitis, myelitis
Measured: 15 months
Secondary outcomes (9)
The evolution of the abnormalities joint structure using ultrasonography
To describe the evolution of ultrasonography parameters during the monitoring and to research a link between those ultrasonography parameters and prognostic indicators : ultrasonography parameters at day 0, Day 4, Day 15, and 3 months.
Measured: 15 months
Return delay apyrexia
To describe the evolution of ultrasonography parameters during the monitoring and to research a link between those ultrasonography parameters and prognostic indicators : Return delay apyrexia.
Measured: 15 months
Delay of surgical management
To describe the evolution of ultrasonography parameters during the monitoring and to research a link between those ultrasonography parameters and prognostic indicators : Delay of surgical management.
Measured: 15 months
Normalization of C Reactive Protein levels
To describe the evolution of ultrasonography parameters during the monitoring and to research a link between those ultrasonography parameters and prognostic indicators : Normalization of C Reactive Protein levels.
Measured: 15 months
Measure of range of motion at 3 months
Measured: 15 months
Percentage of decreased range of motion relative to normal range of motion at 3 months
Measured: 15 months
Pain at rest measured by scale at 3 months
Measured: 15 months
Pain during activity measured by scale at 3 months
Measured: 15 months
Functional outcome score Short Form (SF) 36 at 3 months
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionJul 2015
- Study completionJul 2015
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 Septic ArthritisStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benoît LE GOFF, Doctor, Principal investigator, Nantes University HospitalGrégoire CORMIER, Doctor, Study chair, Centre Hospitalier Departemental VendeeOriane MEROT, Doctor, Principal investigator, CH Saint-Nazaire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02018952
- Sponsor's protocol ID
- RC13_0393
- Acronym
- SEPT'ECHO
- Status last verified
- Mar 2016
- First submitted
- 11 Dec 2013
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Gaigneux E, Cormier G, Varin S, Merot O, Maugars Y, Le Goff B. Ultrasound abnormalities in septic arthritis are associated with functional outcomes. Joint Bone Spine. 2017 Oct;84(5):599-604. doi: 10.1016/j.jbspin.2017.02.002. Epub 2017 Feb 17.
PubMed 28219656
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonography Assessment of Septic Arthritis on Native Joint: a Descriptive, Exploratory, Prospective, Multicentric Trial
- ClinicalTrials.gov ID
- NCT02018952
- Acronym / sponsor ID
- SEPT'ECHO / RC13_0393
- Conditions
- Septic Arthritis
- Keywords
- Septic arthritis, Ultrasonography, Prognosis parameters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 23 Dec 2013 (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 aim of this trial is to study the interest of ultrasonography among patients with septic arthritis.
Currently, ultrasonography is useful for detecting small fluid effusions, for examining otherwise inaccessible joints, such as the hip and for helping the joint aspiration.
Accurate assessment of disease activity and joint damage in septic arthritis is important for monitoring treatment efficiency and for prediction of the outcome of the disease.
Nowadays, magnetic resonance imaging (MRI) provides better resolution than radiography or tomography for the detection of joint effusion and for differentiation between bone and soft tissue infectious. The sensibility is reported to be nearly 100% with a specificity of more than 75%.
However, MRI is expensive and not rapidly accessible.
Therefore, ultrasonography, a non invasive, painless, inexpensive, and non radiating exam can be used to assess the presence and extent of inflammation, destruction, and tissue response.
The objective is to describe, using ultrasonography, the abnormalities joint structure influenced the septic arthritis evolution and prognosis.
The investigators hope, at the end of this study, to evaluate ultrasonography interest in septic arthritis and to establish ultrasonography prognosis factors to predict treatment efficiency and functional outcome.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasonography assessment | Other | Other: Ultrasonography assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Major patients hospitalized in Rheumatology, Infectiology, Orthopedy Department (hospital of Nantes, of La Roche sur Yon and of Saint-Nazaire) with a septic arthritis of shoulder, or elbow, or wrist , or hip, or knee, or ankle on native joint, with positive microbiologic culture joint fluid or positive hemoculture; the diagnosis was based on positive histology or imagery with an inflammatory joint fluid if the microbiologic cultures (hemoculture or joint effusion) were negative.
Key exclusion criteria (4 listed)
- Presence of material on the targeted joint
- Age < 18 years old
- Patients under guardianship
- Pregnancy
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 |
|---|---|---|
| Ultrasonography assessmentAll patients will be seen at day 0, day 4, day 15 and at 3 months. These visits are usually programmed. Only monitoring ultrasonography, a non invasive exam, and self-administered questionnaires will be made, additional to standard exams for all patients included (no control group). Day 0 : * Information of patient and no opposition getting * Clinical exam * Laboratory tests * Radiography of the targeted joint * Ultrasonography of the targeted joint and controlateral joint (about 20 minutes) Day 4 : * Clinical exam * Laboratory tests * Ultrasonography of the targeted joint and controlateral joint (about 20 minutes) Day15 : * Clinical exam * Laboratory tests * Ultrasonography of the targeted joint and controlateral joint (about 20 minutes) M3 : * Clinical exam * Laboratory tests * Radiography of the targeted joint * Ultrasonography of the targeted joint and controlateral joint (about 20 minutes) * Functional outcome | Other | Ultrasonography assessment |
Primary outcome
Abnormalities joint structure influencing the septic arthritis evolution and prognosis
Time frame: 15 months
Ultrasonography description of : * synovium aspect : homogeneous, nodular * maximum thickness synovium * synovium doppler signal (grade 0, 1, 2, 3) * presence and aspect of joint effusion : anechoic, hypo/hyperechoic, heterogeneous * presence and aspect of bone erosions : single, minimal/deep, multiple, minimal/ deep * presence of a synovium partitioning * soft tissue aspect : cellulitis, myelitis
9 secondary outcomes
The evolution of the abnormalities joint structure using ultrasonography
Time frame: 15 months
Return delay apyrexia
Time frame: 15 months
Delay of surgical management
Time frame: 15 months
Normalization of C Reactive Protein levels
Time frame: 15 months
Measure of range of motion at 3 months
Time frame: 15 months
Percentage of decreased range of motion relative to normal range of motion at 3 months
Time frame: 15 months
Pain at rest measured by scale at 3 months
Time frame: 15 months
Pain during activity measured by scale at 3 months
Time frame: 15 months
Functional outcome score Short Form (SF) 36 at 3 months
Time frame: 15 months
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 14 Sep 2026.
- Results publication: PubMed 28219656Gaigneux E, Cormier G, Varin S, Merot O, Maugars Y, Le Goff B. Ultrasound abnormalities in septic arthritis are associated with functional outcomes. Joint Bone Spine. 2017 Oct;84(5):599-604. doi: 10.1016/j.jbspin.2017.02.002. Epub 2017 Feb 17.
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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.
Benoît LE GOFF, Doctor principal investigator
Nantes University Hospital
Grégoire CORMIER, Doctor study chair
Centre Hospitalier Departemental Vendee
Oriane MEROT, Doctor principal investigator
CH Saint-Nazaire
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonography assessment in people with Septic Arthritis, run by Nantes University Hospital at 3 sites 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 1 inclusion and 4 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 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Abnormalities joint structure influencing the septic arthritis evolution and prognosis (time frame: 15 months). 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 NCT02018952, 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 14 Sep 2026.