Exploratory Study of Ultrasound Signs of Native Septic Arthritis of the Knee
USAK
1 other identifier
observational
30
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2021
Longer than P75 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2021
CompletedFirst Posted
Study publicly available on registry
July 7, 2021
CompletedStudy Start
First participant enrolled
October 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedJanuary 19, 2024
January 1, 2024
3.4 years
June 16, 2021
January 18, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
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)
Interventions
Describe the sonographic abnormalities observed at Day 0, Day 10, 6 weeks, 3 months, 6 months, during native septic arthritis of the knee
Eligibility Criteria
Patients with native septic arthritis of the knee
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
CHU de Nantes
Nantes, Pays de la Loire Region, 44093, France
CH D'Angouleme
Angoulême, France
CH de La roche-sur-yon
La Roche-sur-Yon, 85925, France
CH De La Rochelle
La Rochelle, 17019, France
CH de Niort
Niort, France
CHU de Poitiers
Poitiers, France
CHU de Rennes
Rennes, 35203, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
GERVAIS Elisabeth
Poitiers University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2021
First Posted
July 7, 2021
Study Start
October 27, 2021
Primary Completion
April 1, 2025
Study Completion
October 1, 2025
Last Updated
January 19, 2024
Record last verified: 2024-01