NCT06003374

Brief Summary

To establish a new protocol in order to increase ultrasound diagnostic accuracy of pediatrics presented with signs of septic hip .

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2023

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2022

Completed
8 months until next milestone

First Posted

Study publicly available on registry

August 22, 2023

Completed
24 days until next milestone

Study Start

First participant enrolled

September 15, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
Last Updated

August 22, 2023

Status Verified

June 1, 2023

Enrollment Period

1.2 years

First QC Date

December 17, 2022

Last Update Submit

August 12, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • To describe the ultrasound abnormalities seen in Patients with septic hip arthritis.

    To evaluate: 1. Synovial membrane thickness . 2. Synovial membrane vascularity. 3. Presence of a joint effusion. 4. Presence of a joint loculation. 5. Presence of a joint erosions.

    Baseline

Interventions

At international protocol U/S examination is performed from an anterior approach, with the transducer in a sagittal plane parallel to the femoral neck. The patients are positioned supine with the hips in neutral position. Also a coronal view is performed from the lateral approach. Establish a new protocol in the MSK unit to perform hip US, * adductor view: flexion, abduction and lateral rotation of the hip joint with viewing the hip via adductor muscle group. * gluteal view: posterior approach of the hip joint via gluteal region with the patient lying on the contralateral examined hip. Psoas and thigh views: US examination of psoas and quadriceps muscles to exclude the presence of absecess . -finally US guided aspiration under complete a septic condition.

Eligibility Criteria

Age1 Week - 15 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Neonates, infants and children presented with suspected septic hip arthritis.

You may qualify if:

  • Neonates, infants and children presented with suspected septic hip arthritis.

You may not qualify if:

  • DDH

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, Infectious

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

InfectionsArthritisJoint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Dalia khaled Mostafa, Master

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor at diagnostic radiology department at assuit univerity

Study Record Dates

First Submitted

December 17, 2022

First Posted

August 22, 2023

Study Start

September 15, 2023

Primary Completion

December 1, 2024

Study Completion

January 30, 2025

Last Updated

August 22, 2023

Record last verified: 2023-06