An observational study in Joint Infection and Septic Arthritis, sponsored by University of Tennessee. Terminated at 1 site in United States. Open to participants aged 3 Months to 18 Years. Per ClinicalTrials.gov, last updated 2018-11-29.
Sponsored by University of Tennessee · Observational
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.
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 9 is below the median of 240 across 2,136 observational studies indexed under Infections.
Browse Infections studies →University of Tennessee is the lead sponsor of 139 studies on the registry; 21 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.
Counted across the registry records on this site, refreshed daily.
pediatric patients at a tertiary referral center who will receive an intra-articular aspiration
Exclusion Criteria:
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 for reason other than suspected infection
Other: leukocyte esterase test
leukocyte esterase test on fluid removed by intra-articular aspiration
leukocyte esterase level using a leukocyte esterase test strip
A positive leukocyte esterase test strip will be considered an indicator of a septic joint
Time frame: at the time of an intraoperative joint aspiration
baseline leukocyte esterase level for pediatric patients using a leukocyte esterase test strip
Time frame: at the time of intraoperative joint aspiration
This study is terminated, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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University of Tennessee