NCT02860871

Brief Summary

The main objective of this study is to assess the ability of Fiber-optic Evanescent Wave Spectroscopy (FEWS) to discriminate synovial fluids samples of septic arthritis patients from other causes of joint effusion by analyzing ex vivo joint fluid samples collected during routine clinical care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
611

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2016

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 9, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 25, 2017

Status Verified

July 1, 2016

Enrollment Period

2.2 years

First QC Date

July 25, 2016

Last Update Submit

April 24, 2017

Conditions

Joint Effusion

Outcome Measures

Primary Outcomes (1)

  • Diagnosis of the cause of joint effusion

    The final diagnosis of the cause of joint effusion is made by the clinician based on the clinical and laboratory data : septic arthritis or other causes of arthritis.

    through study completion, an average of 6 months

Interventions

infrared spectroscopyOTHER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients benefiting from joint fluid puncture for diagnostic purposes in the rheumatology hospitals participating in the study

You may qualify if:

  • patients benefiting from joint fluid puncture for diagnostic purposes in the rheumatology hospitals participating in the study
  • patients over 18 year old,
  • patients who received information about the protocol and have not expressed opposition to participate.

You may not qualify if:

  • patients opposing the study,
  • patients aged below 18 year old
  • Protected major (safeguard justice , trusteeship and guardianship) and persons deprived of liberty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de RENNES

Rennes, 35033, France

Location

Related Publications (1)

  • Albert JD, Le Corvec M, Berthoud O, David C, Guennoc X, Hoppe E, Jousse-Joulin S, Le Goff B, Tariel H, Sire O, Jolivet-Gougeon A, Coiffier G, Loreal O. Ruling out septic arthritis risk in a few minutes using mid-infrared spectroscopy in synovial fluids. Rheumatology (Oxford). 2021 Mar 2;60(3):1158-1165. doi: 10.1093/rheumatology/keaa373.

    PMID: 32885254DERIVED

MeSH Terms

Conditions

Hydrarthrosis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2016

First Posted

August 9, 2016

Study Start

June 1, 2014

Primary Completion

August 1, 2016

Study Completion

December 1, 2016

Last Updated

April 25, 2017

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)