Skip to main content
OpenTrials
Completed

NCT Number: NCT03819855

External Validation of a Septic Arthritis Prognosis Score

Observational study

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Arthritis Joint Diseases Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rennes University Hospital

Rennes, 35033, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. RESAS (Rennes Septic Arthritis Score)

    Time frame: 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 outcomes

  1. Macroscopic synovial fluid appearance

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

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

  2. Microscopic synovial analysis

    Time frame: Up 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)

  3. Synovial White Cells Count (SWCC)

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

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

  4. Total lactates, D-lactate, glucose

    Time frame: Up 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)

  5. Others synovial proteic markers

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

    Measures of CRP (mg/L) in synovial fluid

  6. Others synovial proteic markers

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

    Measures of Procalcitonine (ng/mL) in synovial fluid

  7. Others synovial proteic markers

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

    Measures of Calprotectin (ng/mL) in synovial fluid

  8. Multielemental analysis by ICP-MS

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

    Screening multielemental in synovial fluid

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

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

    Fever (expressed in Celcius degree)

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

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

    Duration of symptoms (expressed in day)

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

    Time frame: Up 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)

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

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

    Number of joints affected (Ordinal variable)

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

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

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

  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

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

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

Acronym: SYNOLACTATES +

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 29, 2019
Registry last updated
Mar 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.