Clinical Trial: Utilization of Leukocyte Esterase in the Diagnosis of Pediatric Joint Infections

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Observational

Official Title: Utilization of Leukocyte Esterase in the Diagnosis of Pediatric Joint Infections

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 Summary: 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.
Sponsor: University of Tennessee

Current Primary Outcome: leukocyte esterase level using a leukocyte esterase test strip [ Time Frame: at the time of an intraoperative joint aspiration ]

Original Primary Outcome: Same as current

Current Secondary Outcome: baseline leukocyte esterase level for pediatric patients using a leukocyte esterase test strip [ Time Frame: at the time of intraoperative joint aspiration ]

Original Secondary Outcome: Same as current

Information By: University of Tennessee

Dates:
Date Received: December 20, 2013
Date Started: December 2013
Date Completion:
Last Updated: July 6, 2015
Last Verified: March 2015