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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06003374
Other study ID # US in pediateric septic hip.
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 15, 2023
Est. completion date January 30, 2025

Study information

Verified date June 2023
Source Assiut University
Contact Dalia khaled Mostafa, Master
Phone 01096638658
Email daliakhaled46@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 46
Est. completion date January 30, 2025
Est. primary completion date December 1, 2024
Accepts healthy volunteers
Gender All
Age group 1 Week to 15 Years
Eligibility Inclusion Criteria: - Neonates, infants and children presented with suspected septic hip arthritis. Exclusion Criteria: - DDH

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Ultrasound
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary To describe the ultrasound abnormalities seen in Patients with septic hip arthritis. To evaluate:
Synovial membrane thickness .
Synovial membrane vascularity.
Presence of a joint effusion.
Presence of a joint loculation.
Presence of a joint erosions.
Baseline
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