Clinical trial NCT02032732: Utilization of Leukocyte Esterase in the Diagnosis of Pediatric Joint Infections
Official title: Utilization of Leukocyte Esterase in the Diagnosis of Pediatric Joint Infections
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Joint Infection
Septic Arthritis
Lead sponsor: University of Tennessee
Sponsor class: OTHER
First posted: 2014-01-10
Enrollment: 9
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pediatric patients at a tertiary referral center who will receive an intra-articular aspiration

Brief summary: Pediatric joint infections are a common diagnostic dilemma encountered by treating orthopaedic surgeons. No single test is sensitive or specific enough to stand alone in determining the presence of joint infection.

The purpose of this study is to test the usefulness of a chemical test strip to detect infection in fluid that is removed from a joint (intra-articular aspiration) in pediatric patients. The test strip measures an enzyme called leukocyte esterase, which has been shown to be useful in detecting the presence of infection in fluids from other parts of the body. This study will assess the efficacy of the leukocyte esterase test as a diagnostic tool for evaluating pediatric joint infections. The hypothesis of the study is that a positive leukocyte esterase test identifies a septic joint in pediatric patients undergoing intraoperative joint aspiration.

Detailed description: Pediatric patients requiring an intra-articular joint aspiration for suspected infection or for other reasons will have a leukocyte esterase test performed on fluid removed from the joint. A convenience sample of consecutive patients will be screened according to inclusion/exclusion criteria and enrolled in the study by informed consent. All patients who will be screened for the study will have already been identified as needing an intra-articular joint aspiration in accordance with standard of care. All patients who are enrolled in the study will have the leukocyte esterase test performed on the fluid that is aspirated. Results of the test strip will be recorded.

Eligibility criteria: Inclusion Criteria:

* All patients at this facility over the age of 3 months and below the age of 18 years who receive an intra-articular aspiration

Exclusion Criteria:

* Immunocompromised patients
* Renal failure patients
* Patients younger than 3 months old
* Patients 18 years of age or older
* Volume of aspirate is less than 1.5 mL

Primary outcomes:
measure: leukocyte esterase level using a leukocyte esterase test strip
timeFrame: at the time of an intraoperative joint aspiration
Secondary outcomes:
measure: baseline leukocyte esterase level for pediatric patients using a leukocyte esterase test strip
timeFrame: at the time of intraoperative joint aspiration
Other outcomes:
Locations:
city: Chattanooga
country: United States
facility: Children's Orthopaedics, Erlanger Health System
state: Tennessee
Study officials:
affiliation: UTCOM Chattanooga/Erlanger Health System
name: Julie Zielinski, M.D.
role: PRINCIPAL_INVESTIGATOR
References: