NCT03819855

Brief Summary

Observational study

Trial Health

87
On Track

Trial Health Score

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

Enrollment
244

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

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

First Submitted

Initial submission to the registry

January 11, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 29, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

March 12, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2021

Completed
Last Updated

March 3, 2021

Status Verified

March 1, 2021

Enrollment Period

1.9 years

First QC Date

January 11, 2019

Last Update Submit

March 2, 2021

Conditions

Arthritis

Outcome Measures

Primary Outcomes (1)

  • RESAS (Rennes Septic Arthritis Score)

    Composite score of 4 biological variables of the synovial liquid (macroscopically purulent liquid and/or Synovial White Cells Counts (SWCC) ≥ 75000/mm3, synovial crystal vizualization, synovial lactate dosage, synovial glucose dosage). Each variable is weighted as follows: macroscopically purulent liquid or SWCC ≥ 75000/mm3 (+3 points), UMS (-4 points) or CPP (-2 points) crystal Vizualization, lactate ≥ 11.5 mmol/L (+6 points) or 10-11.4 mmol/L (+4 points) or 8.5-9.9 mmol/L (+2 points), glucose ≤ 1.0 mmol/L (+4 points), 1.1-1.8 mmol/L (+2 points), yielding a total between -4 and 13.

    Up to 3 days (time to collect laboratory results)

Secondary Outcomes (14)

  • Macroscopic synovial fluid appearance

    Up to 1 day (time to collect clinical parameters)

  • Microscopic synovial analysis

    Up to 3 days (time to collect laboratory results)

  • Synovial White Cells Count (SWCC)

    Up to 3 days (time to collect laboratory results)

  • Total lactates, D-lactate, glucose

    Up to 3 days (time to collect laboratory results)

  • Others synovial proteic markers

    Up to 3 days (time to collect laboratory results)

  • +9 more secondary outcomes

Eligibility Criteria

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

Patients performing joint puncture in routine care as part of a diagnostic assessment of acute arthritis

You may qualify if:

  • Any acute arthritis less than or equal to 30 days;
  • Achievement of a joint puncture in routine care as part of the diagnostic assessment of this acute arthritis;
  • Affiliation to a social security scheme;
  • No one opposes his participation in the research.

You may not qualify if:

  • Age below 18 years;
  • Major persons subject to legal protection (safeguard of justice, guardianship, guardianship), persons deprived of their liberty.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rennes University Hospital

Rennes, 35033, France

Location

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Guillaume Coiffier

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 11, 2019

First Posted

January 29, 2019

Study Start

March 12, 2019

Primary Completion

February 15, 2021

Study Completion

February 15, 2021

Last Updated

March 3, 2021

Record last verified: 2021-03

Locations

FR(1)