An observational study in Hip Effusion, Septic Arthritis and Transient Synovitis, Hip, sponsored by Connecticut Children's Medical Center. Completed at 6 sites in 2 countries. Open to participants aged 1 Month to 18 Years. Per ClinicalTrials.gov, last updated 2024-08-22.
Sponsored by Connecticut Children's Medical Center · Observational
The purpose of this study is to determine if pediatric emergency medicine providers can accurately diagnose a hip effusion using point-of-care ultrasound (POCUS) compared to radiology ultrasound (RADUS).
The purpose of this study is to determine that the accuracy of trained pediatric emergency medicine providers to diagnose hip effusion using point-of-care ultrasound (POCUS) is non-inferior to the reference standard of radiology ultrasound (RADUS). Additionally, the investigators seek to compare how POCUS performs against other clinical tests or investigations for the diagnosis of septic arthritis. The investigators hypothesize that trained EM providers will be able to diagnose hip effusions with high (>90%) accuracy compared to studies conducted by the Department of Radiology.
126 studies on the registry are indexed under Arthritis, Infectious; 25 are open to participants now.
This study's enrollment of 161 is above the median of 100 across 73 observational studies indexed under Arthritis, Infectious.
Browse Arthritis, Infectious studies →Connecticut Children's Medical Center is the lead sponsor of 59 studies on the registry; 13 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
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The target population are children 18 years and younger presenting to the Emergency Department at Connecticut Children's Medical Center with a chief complaint that necessitates hip ultrasonography as determined by the physician caring for the patient at the time of the visit. Those presenting during the study period of October 2019-December 2023 will be recruited. This is a multi-center, international study that will also be conducted in the Pediatric Emergency Departments at the following institutions: Connecticut Children's, Cohen Children's Medical Center, New York-Presbyterian / Columbia University Medical Center, Yale New Haven Hospital, Newark Beth Israel Medical Center, and Gold Coast Hospital (Queensland, Australia).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The presence or absence of a hip effusion.
The presence or absence of an effusion as determined by the pediatric emergency medicine physician performing the point-of-care-ultrasound study on both the affected and unaffected sides (i.e. right hip and left hip).
Time frame: From the time the point-of-care ultrasound is performed by the physician during the emergency department visit through study completion, average of 2 years.
The presence of absence of a hip effusion.
The presence or absence of an effusion as determined by the Radiologist on both the affected and unaffected sides.
Time frame: From the time the radiologist reviews the ultrasound as performed by the radiology technician during the emergency department visit, through study completion, average of 2 years.
The size of the effusion.
As measured by the pediatric emergency medicine provider in millimeters.
Time frame: From the time the point-of-care ultrasound is performed by the physician during the emergency department visit to study completion, average of 2 years
The location of the measurement of the effusion.
Pediatric emergency medicine physicians will measure an effusion at two designated locations. One location is based off of current published literature whereas the second is to provide a comparison to determine if the exact location alters the final diagnosis (effusion or no effusion). Investigators will determine whether the location along the angle of the neck affects the measurement obtained when compared with the current standard practice of measuring fluid along the widest part of the femoral neck.
Time frame: Upon chart review: between the time the measurement was obtained in the emergency department up to six weeks later when the chart is reviewed by primary investigator.
Number of point-of-care ultrasound studies performed by PEM providers that have a different final diagnosis when compared to radiology ultrasound.
Investigators will compare the final diagnosis (hip effusion or no hip effusion) between point-of-care-ultrasound and radiology ultrasound to determine the number of discrepancies between the groups.
Time frame: Upon chart review: between the time the measurement was obtained in the emergency department up to six weeks later when the chart is reviewed by primary investigator.
Association between point-of-care ultrasound and Kocher score (0-4).
Investigators will determine if the addition of ultrasonography results coupled with Kocher score (0-4; increased risk of septic arthritis with higher scores), which includes laboratory markers, increases the likelihood of septic arthritis.
Time frame: Upon chart review: between the time the measurement was obtained in the emergency department up to six weeks later when the chart is reviewed by primary investigator.
Plan to share: Yes — Each study site will enter data into Redcap hosted by the lead site, Connecticut Children's. Data will be available for review and combined by Connecticut Children's investigators for data analysis. Each participating site has completed a data use agreement with the lead site agreeing to this plan.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Shared as patients are seen throughout the course of the study.
Access criteria: Only the designated study investigator at each participating site will have Redcap access for purposes of data entry only. Primary investigators at the lead site will have access to the combined data set for data analyses.
Ran from Oct 2019 to primary completion in Apr 2024, 54 months.
Of 29 observational studies under Arthritis, Infectious, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 185. This study's 54 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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