NCT04720066

Brief Summary

Limping is a common complaint among children presenting in the Pediatric ED the evaluation of a limp among infants and toddlers is challenging doe to the lack of specific history and the difficulty in locating the pain - therefore hip sonography is frequently used in the clinical evaluation of these children. Sonographic examination for the diagnosis of hip effusion is routinely performed by the radiologist, however, since the integration of Point of care Ultrasound (POCUS) as part of the clinical evaluation of children in the ED in many application - Hip pocus is frequently performed by pediatric Emergency Medicine physicians. The existing data on hip POCUS is scarce and comprised of small uncontrolled studies. We aimed to examine the specificity and sensitivity of hip Pocus performed by pediatric emergency physicians by comparing it to the scan performed by the radiologist. the primary outcome measurement is the ability of the POCUS exam to identify or rule out the existence of hip effusion as demonstrated in the formal radiological Ultrasound scan.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

October 26, 2021

Status Verified

October 1, 2021

Enrollment Period

1.3 years

First QC Date

January 19, 2021

Last Update Submit

October 24, 2021

Conditions

Keywords

Hip Effusion, point of care sonography, pediatric,

Outcome Measures

Primary Outcomes (1)

  • accuracy of POCUS examination for the detection of hip effusion among limping children

    POCUS examination results compared to formal radiology ultrasound examination performed .

    both examination are performed during the same 1 day ED visit.

Interventions

Ultrasound testDIAGNOSTIC_TEST

point of care ultrasound performed by PEM physicians to limping children presenting to the PED compared to radiologist performed ultrasound test.

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

* pediatric patients (age 0-18 years) presenting to the PED with the complaint of a limp or a lower limb pain

You may not qualify if:

  • trauma patients
  • patients with an obvious diagnosis other than pain resulting from the hip joint on their physical examination.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ayelet Shles

Kfar Saba, Israel

RECRUITING

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2021

First Posted

January 22, 2021

Study Start

September 1, 2020

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

October 26, 2021

Record last verified: 2021-10

Locations