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Utilization of Leukocyte Esterase in the Diagnosis of Pediatric Joint Infections

Utilization of Leukocyte Esterase in the Diagnosis of Pediatric Joint Infections

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02032732
Enrollment
9
Registered
2014-01-10
Start date
2013-12-31
Completion date
2016-12-31
Last updated
2018-11-29

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

Conditions

Joint Infection, Septic Arthritis

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.

Interventions

OTHERleukocyte esterase test

leukocyte esterase test on fluid removed by intra-articular aspiration

Sponsors

University of Tennessee
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Months to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
leukocyte esterase level using a leukocyte esterase test stripat the time of an intraoperative joint aspirationA positive leukocyte esterase test strip will be considered an indicator of a septic joint

Secondary

MeasureTime frame
baseline leukocyte esterase level for pediatric patients using a leukocyte esterase test stripat the time of intraoperative joint aspiration

Countries

United States

Outcome results

None listed

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