External Validation of a Septic Arthritis Prognosis Score

Arthritis Clinical Trial

— SYNOLACTATES +  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03819855
• Other study ID #: 35RC18_30015_SYNOLACTATES-PLUS
• Status: Completed
• Start date: March 12, 2019
• Est. completion date: February 15, 2021

Study information

• Verified date: March 2021
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Observational study

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: February 15, 2021
• Est. primary completion date: February 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Infectious

Locations

Country	Name	City	State
France	Rennes University Hospital	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Macroscopic synovial fluid appearance	Expressed in multiple qualitative variable: purulent, trouble, clear citrine appearance, hemarthrosis or clear with blood threads	Up to 1 day (time to collect clinical parameters)
Secondary	Microscopic synovial analysis	Presence of crystals in synovial fluid: urate monosodic (UMS) crystal (Yes or No), and calcium pyrophosphate crystal (CPP) (Yes or No)	Up to 3 days (time to collect laboratory results)
Secondary	Synovial White Cells Count (SWCC)	Number (n) of White cells in synovial fluid. (quantitative variable expressed in n/mm3)	Up to 3 days (time to collect laboratory results)
Secondary	Total lactates, D-lactate, glucose	Measures of total lactate, D-lactate et glucose in synovial fluid (quantitative variable expressed in mmol/L)	Up to 3 days (time to collect laboratory results)
Secondary	Others synovial proteic markers	Measures of CRP (mg/L) in synovial fluid	Up to 3 days (time to collect laboratory results)
Secondary	Others synovial proteic markers	Measures of Procalcitonine (ng/mL) in synovial fluid	Up to 3 days (time to collect laboratory results)
Secondary	Others synovial proteic markers	Measures of Calprotectin (ng/mL) in synovial fluid	Up to 3 days (time to collect laboratory results)
Secondary	Multielemental analysis by ICP-MS	Screening multielemental in synovial fluid	Up to 3 days (time to collect laboratory results)
Secondary	Number of classical clinical marker (quantitative variable) to diagnosis of septic arthritis	Fever (expressed in Celcius degree)	Up to 1 day (time to collect clinical parameters)
Secondary	Number of classical clinical marker (quantitative variable) to diagnosis of septic arthritis	Duration of symptoms (expressed in day)	Up to 1 day (time to collect clinical parameters)
Secondary	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)	Up to 1 day (time to collect clinical parameters)
Secondary	Number of classical clinical marker (qualitative variable) to diagnosis of septic arthritis	Number of joints affected (Ordinal variable)	Up to 1 day (time to collect clinical parameters)
Secondary	Parameters that may influence the bacteriological results of synovial fluid	NSAIDs, corticosteroids, antibiotics within 15 days of joint puncture (qualitative variable: Yes or No)	Up to 1 day (time to collect clinical parameters)
Secondary	Number of hospitalization potentially avoided by the early elimination of an arthritis diagnosis and their cost, from the point of view of illness insurance		Date of hospitalization until 2 months of follow-up