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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04952220
Other study ID # 2021-A01301-40
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 27, 2021
Est. completion date October 2025

Study information

Verified date January 2024
Source Poitiers University Hospital
Contact GERVAIS Elisabeth
Phone 05 49 44 44 65
Email elisabeth.gervais@chu-poitiers.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


Description:

Secondary Objectives: 1. Search for poor prognostic factors in native septic arthritis of the knee. 2. To look for an association between initial sonographic factors and the use of joint lavage. 3. Look for associations between sonographic signs and clinico-radio-biologic factors at each visit (D10, 6 weeks, 3 months and 6 months)


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date October 2025
Est. primary completion date April 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
ultrasound
Describe the sonographic abnormalities observed at Day 0, Day 10, 6 weeks, 3 months, 6 months, during native septic arthritis of the knee

Locations

Country Name City State
France CH D'Angouleme Angoulême
France CH de La roche-sur-yon La Roche-sur-Yon
France CH De La Rochelle La Rochelle
France CHU de Nantes Nantes Pays De La Loire
France CH de Niort Niort
France CHU de Poitiers Poitiers
France CHU de Rennes Rennes

Sponsors (1)

Lead Sponsor Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Day0, Day 10 or before surgery, 6week, 3months, 6months
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