Clinical trial NCT03819855: External Validation of a Septic Arthritis Prognosis Score
Official title: External Validation of the RESAS (REnnes Septic Arthritis Score) Septic Arthritis Prognosis Score in an Acute Arthritis Cohort of Less Than 30 Days
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2019-01-29
Enrollment: 244
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients performing joint puncture in routine care as part of a diagnostic assessment of acute arthritis

Brief summary: Observational study

Detailed description: Septic arthritis is a diagnostic emergency for acute arthritis because it is accompanied by an excess of mortality of 11% and frequent functional sequelae in about 50% of cases in the year. However, it remains rare with an estimated annual incidence of 1 to 5/100000, and a prevalence of about 10% in front of an acute arthritis table sent to an emergency department.

The diagnosis is based on the bacteriological culture which finds the presence of a microorganism within the joint. However, only 80% of septic arthritis is bacteriologically documented due to low inoculum, the presence of fragile bacteria (Neisseria sp) or especially untimely antibiotherapy prior to joint puncture.

In addition, the bacteriological culture takes an average of 3 days to become positive, which may delay the implementation of appropriate antibiotic therapy.

It is therefore essential that the clinician can rely on other clinical or biological parameters, reliable and fast for better diagnostic orientation.

A first study: SYNOLACTATES showed the interest of the measurement of glucose and synovial lactate for the diagnosis of septic arthritis with very good performances. A RESAS score (REnnes Septic Arthritis Score) was constructed from these results to assess the likelihood of septic arthritis.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: RESAS (Rennes Septic Arthritis Score)
timeFrame: Up to 3 days (time to collect laboratory results)
Secondary outcomes:
measure: Macroscopic synovial fluid appearance
timeFrame: Up to 1 day (time to collect clinical parameters)
measure: Microscopic synovial analysis
timeFrame: Up to 3 days (time to collect laboratory results)
measure: Synovial White Cells Count (SWCC)
timeFrame: Up to 3 days (time to collect laboratory results)
measure: Total lactates, D-lactate, glucose
timeFrame: Up to 3 days (time to collect laboratory results)
measure: Others synovial proteic markers
timeFrame: Up to 3 days (time to collect laboratory results)
measure: Others synovial proteic markers
timeFrame: Up to 3 days (time to collect laboratory results)
measure: Others synovial proteic markers
timeFrame: Up to 3 days (time to collect laboratory results)
measure: Multielemental analysis by ICP-MS
timeFrame: Up to 3 days (time to collect laboratory results)
measure: Number of classical clinical marker (quantitative variable) to diagnosis of septic arthritis
timeFrame: Up to 1 day (time to collect clinical parameters)
measure: Number of classical clinical marker (quantitative variable) to diagnosis of septic arthritis
timeFrame: Up to 1 day (time to collect clinical parameters)
measure: Number of classical clinical marker (qualitative variable) to diagnosis of septic arthritis
timeFrame: Up to 1 day (time to collect clinical parameters)
measure: Number of classical clinical marker (qualitative variable) to diagnosis of septic arthritis
timeFrame: Up to 1 day (time to collect clinical parameters)
measure: Parameters that may influence the bacteriological results of synovial fluid
timeFrame: Up to 1 day (time to collect clinical parameters)
measure: Number of hospitalization potentially avoided by the early elimination of an arthritis diagnosis and their cost, from the point of view of illness insurance
timeFrame: Date of hospitalization until 2 months of follow-up
Other outcomes:
Locations:
city: Rennes
country: France
facility: Rennes University Hospital
Study officials:
affiliation: Rennes University Hospital
name: Guillaume Coiffier
role: PRINCIPAL_INVESTIGATOR
References: