Exploratory Study of Ultrasound Signs of Native Septic Arthritis of the Knee

NCT ID: NCT04952220

Last Updated: 2024-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-27

Study Completion Date

2025-10-31

Brief Summary

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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

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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)

Conditions

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Ultrasound Therapy; Complications Septic Arthritis Knee Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

ultrasound

Intervention Type DEVICE

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

Interventions

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ultrasound

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GERVAIS Elisabeth

Role: PRINCIPAL_INVESTIGATOR

Poitiers University Hospital

Locations

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CHU de Nantes

Nantes, Pays de la Loire Region, France

Site Status RECRUITING

CH D'Angouleme

Angoulême, , France

Site Status NOT_YET_RECRUITING

CH de La roche-sur-yon

La Roche-sur-Yon, , France

Site Status RECRUITING

CH De La Rochelle

La Rochelle, , France

Site Status RECRUITING

CH de Niort

Niort, , France

Site Status RECRUITING

CHU de Poitiers

Poitiers, , France

Site Status RECRUITING

CHU de Rennes

Rennes, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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GERVAIS Elisabeth

Role: CONTACT

05 49 44 44 65

Facility Contacts

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Le GOFF Benoit

Role: primary

RICHE Agnes

Role: primary

CORMIER Grégoire

Role: primary

MARTIN Claire

Role: primary

Christian LORMEAU

Role: primary

Rachel BRAULT

Role: primary

Olivia BERTHOUD

Role: primary

Other Identifiers

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2021-A01301-40

Identifier Type: -

Identifier Source: org_study_id

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