Utilization of Leukocyte Esterase in the Diagnosis of Pediatric Joint Infections

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.

Study Overview

• Status: Terminated
• Conditions: Septic Arthritis; Joint Infection
• Intervention / Treatment: Other: leukocyte esterase test

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 Type: Observational
• Enrollment (Actual): 9

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Children's Orthopaedics, Erlanger Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

pediatric patients at a tertiary referral center who will receive an intra-articular aspiration

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
suspected infection; leukocyte esterase test on fluid removed by intra-articular aspiration for suspected infection	Other: leukocyte esterase test; leukocyte esterase test on fluid removed by intra-articular aspiration
no suspected infection; leukocyte esterase test on fluid removed by intra-articular aspiration for reason other than suspected infection	Other: leukocyte esterase test; leukocyte esterase test on fluid removed by intra-articular aspiration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
leukocyte esterase level using a leukocyte esterase test strip	A positive leukocyte esterase test strip will be considered an indicator of a septic joint	at the time of an intraoperative joint aspiration

Secondary Outcome Measures

Outcome Measure	Time Frame
baseline leukocyte esterase level for pediatric patients using a leukocyte esterase test strip	at the time of intraoperative joint aspiration

Collaborators and Investigators

• Sponsor: University of Tennessee
• Investigators: Principal Investigator: Julie Zielinski, M.D., UTCOM Chattanooga/Erlanger Health System

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: December 20, 2013
• First Submitted That Met QC Criteria: January 8, 2014
• First Posted (Estimate): January 10, 2014

Study Record Updates

• Last Update Posted (Actual): November 29, 2018
• Last Update Submitted That Met QC Criteria: November 27, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Joint Diseases; Musculoskeletal Diseases; Arthritis; Infections; Communicable Diseases; Arthritis, Infectious
• Other Study ID Numbers: 13-106