Ultrasound Therapy; ComplicationsUSAKNCT04952220
Exploratory Study of Ultrasound Signs of Native Septic Arthritis of the Knee
An observational study of Ultrasound Therapy; Complications and Septic Arthritis, run by Poitiers University Hospital at 7 sites in France.
Trial summary
Primary objective: Description of ultrasound abnormalities seen in native septic arthritis of the knee during each visit. Primary endpoint: Describe the ultrasound abnormalities observed on Day 0, Day 10, 6 weeks, 3 months, 6 months, during native septic arthritis of the knee. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ultrasound Therapy; Complications, Septic Arthritis, Knee Arthritis
- What is being tested?
- ultrasound
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 7 sitesFrance
- Study dates
- 27 Oct 2021to Oct 2025
- Phase
- Observational
- 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
Study population: Patients with native septic arthritis of the knee
Who may be able to join
- Male or female of legal age
- Bacteriologically proven native septic arthritis
- Meets the definition of septic arthritis: Bacteriological documentation of joint puncture fluid-Native articulation
- Free subject, without guardianship or trusteeship, or subordination
- Non-opposition of the patient after clear and fair information about the study
Who cannot join
- Presence of material in the affected joint
- Arthritis with Mycobacterium Tuberculosis.
- Patients benefiting from a reinforced protection, namely: minors, pregnant and/or breast-feeding women, persons deprived of liberty by a judicial or administrative decision, adults under legal protection
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites, 7 recruiting
- Not yet recruiting
CH D'Angouleme
Angoulême
RICHE Agnes, agnes.riche@ch-angouleme.fr
- Recruiting
CH de La roche-sur-yon
La Roche-sur-Yon, 85925
CORMIER Grégoire, gregoire.cormier@chd-vendee.fr
- Recruiting
CH De La Rochelle
La Rochelle, 17019
MARTIN Claire, Claire.MARTIN@ch-larochelle.fr
- Recruiting
CHU de Nantes
Nantes, Pays de la Loire Region, 44093
Le GOFF Benoit, :Benoit.LEGOFF@chu-nantes.fr
- Recruiting
CH de Niort
Niort
Christian LORMEAU, christian.lormeau@ch-niort.fr
- Recruiting
CHU de Poitiers
Poitiers
Rachel BRAULT, rachel.brault@chu-poitiers.fr
- Recruiting
CHU de Rennes
Rennes, 35203
Olivia BERTHOUD, olivia.berthoud@chu-rennes.fr
About this study
Primary objective: Description of ultrasound abnormalities seen in native septic arthritis of the knee during each visit.
Primary endpoint: Describe the ultrasound abnormalities observed on Day 0, Day 10, 6 weeks, 3 months, 6 months, during native septic arthritis of the knee.
Read the detailed description
Secondary Objectives:
- Search for poor prognostic factors in native septic arthritis of the knee.
- To look for an association between initial sonographic factors and the use of joint lavage.
- Look for associations between sonographic signs and clinico-radio-biologic factors at each visit (D10, 6 weeks, 3 months and 6 months)
- Being tested
- ultrasound
- Medical subject headings
- Arthritis, Infectious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDevice
Describe the sonographic abnormalities observed at Day 0, Day 10, 6 weeks, 3 months, 6 months, during native septic arthritis of the knee
| Study group | Role | What they receive |
|---|---|---|
| native septic arthritis of the knee | Describe the ultrasound abnormalities observed at D0, D10 or before surgery, 6 weeks, 3 months, 6 months, during native septic arthritis of the knee:
thickness and vascularity of the synovial membrane, existence and measurement of joint effusion existence of articular partitioning, erosions and adjacent soft tissue involvement (muscle abscess, cellulitis) Receives: Device: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
description of the ultrasound abnormalities seen in native septic arthritis of the knee
Describe the ultrasonographic abnormalities seen in native septic arthritis of the knee
Measured: Day0, Day 10 or before surgery, 6week, 3months, 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start27 Oct 2021
- Primary completionApr 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasound Therapy; ComplicationsStudies of the same condition, open and under way.
- More trials run by Poitiers 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- GERVAIS Elisabeth, Principal investigator, Poitiers University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04952220
- Sponsor's protocol ID
- 2021-A01301-40
- Acronym
- USAK
- Status last verified
- Jan 2024
- First submitted
- 16 Jun 2021
- Last updated
- 19 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of Ultrasound Signs of Native Septic Arthritis of the Knee
- ClinicalTrials.gov ID
- NCT04952220
- Acronym / sponsor ID
- USAK / 2021-A01301-40
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 27 Oct 2021 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 7 Jul 2021 (actual)
- 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.
Primary objective: Description of ultrasound abnormalities seen in native septic arthritis of the knee during each visit.
Primary endpoint: Describe the ultrasound abnormalities observed on Day 0, Day 10, 6 weeks, 3 months, 6 months, during native septic arthritis of the knee.
Detailed description
Secondary Objectives:
- Search for poor prognostic factors in native septic arthritis of the knee.
- To look for an association between initial sonographic factors and the use of joint lavage.
- Look for associations between sonographic signs and clinico-radio-biologic factors at each visit (D10, 6 weeks, 3 months and 6 months)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| native septic arthritis of the knee | – | Device: ultrasoundDescribe the ultrasound abnormalities observed at D0, D10 or before surgery, 6 weeks, 3 months, 6 months, during native septic arthritis of the knee: thickness and vascularity of the synovial membrane, existence and measurement of joint effusion existence of articular partitioning, erosions and adjacent soft tissue involvement (muscle abscess, cellulitis) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with native septic arthritis of the knee
Key inclusion criteria (5 listed)
- Male or female of legal age
- Bacteriologically proven native septic arthritis
- Meets the definition of septic arthritis: Bacteriological documentation of joint puncture fluid-Native articulation
- Free subject, without guardianship or trusteeship, or subordination
- Non-opposition of the patient after clear and fair information about the study
Key exclusion criteria (3 listed)
- Presence of material in the affected joint
- Arthritis with Mycobacterium Tuberculosis.
- Patients benefiting from a reinforced protection, namely: minors, pregnant and/or breast-feeding women, persons deprived of liberty by a judicial or administrative decision, adults under legal protection
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 |
|---|---|---|
| ultrasoundDescribe the sonographic abnormalities observed at Day 0, Day 10, 6 weeks, 3 months, 6 months, during native septic arthritis of the knee | Device | native septic arthritis of the knee |
Primary outcome
description of the ultrasound abnormalities seen in native septic arthritis of the knee
Time frame: Day0, Day 10 or before surgery, 6week, 3months, 6months
Describe the ultrasonographic abnormalities seen in native septic arthritis of the knee
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
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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.
GERVAIS Elisabeth principal investigator
Poitiers University Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasound Therapy; Complications and Septic Arthritis, run by Poitiers University Hospital at 7 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact GERVAIS Elisabeth (05 49 44 44 65, elisabeth.gervais@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
description of the ultrasound abnormalities seen in native septic arthritis of the knee (time frame: Day0, Day 10 or before surgery, 6week, 3months, 6months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jan 2024.