- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06003374
Extended Hip Ultrasound as Anew Protocol for Septic Hip in Children
August 12, 2023 updated by: Dalia Khaled Mostafa Mohamed, Assiut University
To establish a new protocol in order to increase ultrasound diagnostic accuracy of pediatrics presented with signs of septic hip .
Study Overview
Detailed Description
Septic arthritis is a severe life and function threatening condition with a 1-year mortality rate of up to 10% and residual functional impairments in 30% to 50% of cases .
Pediatric Septic Hip Arthritis is an intra-articular infection in children that peaks in the first few years of life.
The incidence of septic arthritis is low, with about 4-5 per 100000 child annually with about 50% of cases occur in children younger than 2 years of age with gender affection in male > female (2:1 ratio).
The hip joint involved in about 35% of all cases of septic arthritis.
Imaging studies contribute crucially to the optimal management of septic arthritis, thereby diminishing the risk of permanent functional loss .At present; magnetic resonance imaging (MRI) is the most informative method.
Thus, MRI assesses the severity of the synovitis and can detect a joint effusion, bone and/or cartilage destruction, an abscess, and/or bone edema.
MRI had 75% specificity and nearly 100% sensitivity for diagnosing concomitant abscess formation, cellulitis, or myositis .
Disadvantages of MRI are high cost and limited availability on an emergency basis in some settings , Ultrasonography of the bone and joints has been developing at a fast pace in recent years.
Ultrasonography is currently used in the management of septic arthritis to confirm the presence of a joint effusion and to guide the joint aspiration or synovial biopsy, particularly when the effusion is small or the joint deep (e.g., hip).
Ultrasonography has high sensitivity and specificity for joint effusions .The difficulty of applying hip MRI in pediatric age group patients especially neonates make challenge in the proper management of acute septic hip arthritis .the
study aim to apply a new protocol in diagnosis of septic hip in children by doing extended hip ultrasound included psoas and quadriceps muscles.
Study Type
Observational
Enrollment (Estimated)
46
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dalia khaled Mostafa, Master
- Phone Number: 01096638658
- Email: daliakhaled46@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Neonates, infants and children presented with suspected septic hip arthritis.
Description
Inclusion Criteria:
- Neonates, infants and children presented with suspected septic hip arthritis.
Exclusion Criteria:
- DDH
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To describe the ultrasound abnormalities seen in Patients with septic hip arthritis.
Time Frame: Baseline
|
To evaluate:
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 15, 2023
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
January 30, 2025
Study Registration Dates
First Submitted
December 17, 2022
First Submitted That Met QC Criteria
August 12, 2023
First Posted (Actual)
August 22, 2023
Study Record Updates
Last Update Posted (Actual)
August 22, 2023
Last Update Submitted That Met QC Criteria
August 12, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- US in pediateric septic hip.
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Septic Arthritis
-
Sheffield Children's NHS Foundation TrustRecruitingSeptic Arthritis | Musculoskeletal Infection | Osteomyelitis/Septic ArthritisUnited Kingdom
-
University Hospital, Strasbourg, FranceRecruiting
-
Assistance Publique - Hôpitaux de ParisNot yet recruitingSeptic ArthritisFrance
-
Universitaire Ziekenhuizen KU LeuvenActive, not recruitingSeptic Arthritis of the Native Hip | Failure of Initial DebridementBelgium
-
Assistance Publique - Hôpitaux de ParisCompletedJuvenile Idiopathic Arthritis | Arthritis, Septic | Arthritis, UnspecifiedFrance
-
wangxiaodongCompleted
-
Second Affiliated Hospital, School of Medicine,...Completed
-
Rennes University HospitalCompleted
-
University Hospital, GenevaCompletedArthritis, SepticSwitzerland
-
Assiut UniversityNot yet recruiting
Clinical Trials on Ultrasound
-
Ahram Canadian UniversityCompletedCarpal Tunnel Syndrome | Median Neuropathy, Carpal TunnelEgypt
-
Eskisehir Osmangazi UniversityCompletedCarpal Tunnel Syndrome
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Withdrawn
-
Cairo UniversityUnknown
-
Ohio State University Comprehensive Cancer CenterWithdrawn
-
Oregon Health and Science UniversityRecruiting
-
Yale UniversityCompletedPneumonia | Pulmonary Edema | DyspneaUnited States
-
Odense University HospitalEnrolling by invitationThoracic Ultrasound | Fibrosing Interstitial Lung DiseasesDenmark
-
Bursa Yüksek İhtisas Education and Research HospitalCompletedShoulder Impingement Syndrome | Shoulder PainTurkey
-
John PelleritoGeneral ElectricActive, not recruiting