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CompletedNCT03819855SYNOLACTATES +Updated Mar 3, 2021

External Validation of a Septic Arthritis Prognosis Score

An observational study in Arthritis, sponsored by Rennes University Hospital. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-03.

Sponsored by Rennes University Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
244
Ages
18 Years and older
Sex
All
01

Study summary

Observational study

Read the 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.

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Conditions studied

03

In context

Arthritis, Infectious

123 studies on the registry are indexed under Arthritis, Infectious; 25 are open to participants now.

This study's enrollment of 244 is above the median of 100 across 72 observational studies indexed under Arthritis, Infectious.

Browse Arthritis, Infectious studies →

Lead sponsor

Rennes University Hospital is the lead sponsor of 440 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

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

Observational model
Case-only
Time perspective
Prospective
Enrollment
244 participants (actual)
Patient registry
No
06

What researchers measure

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.

    Time frame: Up to 3 days (time to collect laboratory results)

Secondary outcomes

  1. Macroscopic synovial fluid appearance

    Expressed in multiple qualitative variable: purulent, trouble, clear citrine appearance, hemarthrosis or clear with blood threads

    Time frame: Up to 1 day (time to collect clinical parameters)

  2. Microscopic synovial analysis

    Presence of crystals in synovial fluid: urate monosodic (UMS) crystal (Yes or No), and calcium pyrophosphate crystal (CPP) (Yes or No)

    Time frame: Up to 3 days (time to collect laboratory results)

  3. Synovial White Cells Count (SWCC)

    Number (n) of White cells in synovial fluid. (quantitative variable expressed in n/mm3)

    Time frame: Up to 3 days (time to collect laboratory results)

  4. Total lactates, D-lactate, glucose

    Measures of total lactate, D-lactate et glucose in synovial fluid (quantitative variable expressed in mmol/L)

    Time frame: Up to 3 days (time to collect laboratory results)

  5. Others synovial proteic markers

    Measures of CRP (mg/L) in synovial fluid

    Time frame: Up to 3 days (time to collect laboratory results)

  6. Others synovial proteic markers

    Measures of Procalcitonine (ng/mL) in synovial fluid

    Time frame: Up to 3 days (time to collect laboratory results)

  7. Others synovial proteic markers

    Measures of Calprotectin (ng/mL) in synovial fluid

    Time frame: Up to 3 days (time to collect laboratory results)

  8. Multielemental analysis by ICP-MS

    Screening multielemental in synovial fluid

    Time frame: Up to 3 days (time to collect laboratory results)

  9. Number of classical clinical marker (quantitative variable) to diagnosis of septic arthritis

    Fever (expressed in Celcius degree)

    Time frame: Up to 1 day (time to collect clinical parameters)

  10. Number of classical clinical marker (quantitative variable) to diagnosis of septic arthritis

    Duration of symptoms (expressed in day)

    Time frame: Up to 1 day (time to collect clinical parameters)

  11. Number of classical clinical marker (qualitative variable) to diagnosis of septic arthritis

    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)

    Time frame: Up to 1 day (time to collect clinical parameters)

  12. Number of classical clinical marker (qualitative variable) to diagnosis of septic arthritis

    Number of joints affected (Ordinal variable)

    Time frame: Up to 1 day (time to collect clinical parameters)

  13. Parameters that may influence the bacteriological results of synovial fluid

    NSAIDs, corticosteroids, antibiotics within 15 days of joint puncture (qualitative variable: Yes or No)

    Time frame: Up to 1 day (time to collect clinical parameters)

  14. Number of hospitalization potentially avoided by the early elimination of an arthritis diagnosis and their cost, from the point of view of illness insurance

    Time frame: Date of hospitalization until 2 months of follow-up

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Study locations

1 site
  • Rennes University Hospital
    Rennes, 35033, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03819855
Lead sponsor
Rennes University Hospital
Responsible party
Sponsor
First posted
Jan 29, 2019
Start date
Mar 12, 2019
Primary completion
Feb 15, 2021
Completion
Feb 15, 2021
Last update
Mar 3, 2021

Study contacts

Guillaume Coiffier
principal investigator · Rennes University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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