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External Validation of a Septic Arthritis Prognosis Score

External Validation of the RESAS (REnnes Septic Arthritis Score) Septic Arthritis Prognosis Score in an Acute Arthritis Cohort of Less Than 30 Days

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03819855
Acronym
SYNOLACTATES +
Enrollment
244
Registered
2019-01-29
Start date
2019-03-12
Completion date
2021-02-15
Last updated
2021-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

None listed

Sponsors

Rennes University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
RESAS (Rennes Septic Arthritis Score)Up to 3 days (time to collect laboratory results)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.

Secondary

MeasureTime frameDescription
Multielemental analysis by ICP-MSUp to 3 days (time to collect laboratory results)Screening multielemental in synovial fluid
Macroscopic synovial fluid appearanceUp to 1 day (time to collect clinical parameters)Expressed in multiple qualitative variable: purulent, trouble, clear citrine appearance, hemarthrosis or clear with blood threads
Microscopic synovial analysisUp to 3 days (time to collect laboratory results)Presence of crystals in synovial fluid: urate monosodic (UMS) crystal (Yes or No), and calcium pyrophosphate crystal (CPP) (Yes or No)
Synovial White Cells Count (SWCC)Up to 3 days (time to collect laboratory results)Number (n) of White cells in synovial fluid. (quantitative variable expressed in n/mm3)
Others synovial proteic markersUp to 3 days (time to collect laboratory results)Measures of CRP (mg/L) in synovial fluid
Number of classical clinical marker (quantitative variable) to diagnosis of septic arthritisUp to 1 day (time to collect clinical parameters)Fever (expressed in Celcius degree)
Number of classical clinical marker (qualitative variable) to diagnosis of septic arthritisUp to 1 day (time to collect clinical parameters)Co-morbidity promoting infection (diabetes, cirrhosis, HIV, severe chronic renal failure, rheumatoid arthritis, other inflammatory rheumatic diseases, immunosuppressive treatments such as corticosteroids, conventional synthetic-DMARDs, biological-DMARDs) (Yes or No)
Parameters that may influence the bacteriological results of synovial fluidUp to 1 day (time to collect clinical parameters)NSAIDs, corticosteroids, antibiotics within 15 days of joint puncture (qualitative variable: Yes or No)
Number of hospitalization potentially avoided by the early elimination of an arthritis diagnosis and their cost, from the point of view of illness insuranceDate of hospitalization until 2 months of follow-up
Total lactates, D-lactate, glucoseUp to 3 days (time to collect laboratory results)Measures of total lactate, D-lactate et glucose in synovial fluid (quantitative variable expressed in mmol/L)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026