Utilization of Leukocyte Esterase in the Diagnosis of Pediatric Joint Infections

Terminated

• Conditions: Joint Infection; Septic Arthritis
• Interventions: Other: leukocyte esterase test

• Registration Number: NCT02032732
• Lead Sponsor: University of Tennessee

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.

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-20
• Study First Submitted QC: 2014-01-08
• Study First Posted: 2014-01-10
• Primary Completion: 2015-12
• Study Completion: 2016-12
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-27
• Last Update Posted: 2018-11-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
suspected infection	leukocyte esterase test	leukocyte esterase test on fluid removed by intra-articular aspiration for suspected infection
no suspected infection	leukocyte esterase test	leukocyte esterase test on fluid removed by intra-articular aspiration for reason other than suspected infection

Primary Outcome Measures

Name	Time	Method
leukocyte esterase level using a leukocyte esterase test strip	at the time of an intraoperative joint aspiration	A positive leukocyte esterase test strip will be considered an indicator of a septic joint

Secondary Outcome Measures

Name	Time	Method
baseline leukocyte esterase level for pediatric patients using a leukocyte esterase test strip	at the time of intraoperative joint aspiration

Trial Locations

Locations (1)

Children's Orthopaedics, Erlanger Health System; 🇺🇸 Chattanooga, Tennessee, United States