Septic ArthritisNCT06003374
Extended Hip Ultrasound as Anew Protocol for Septic Hip in Children
An observational study of Septic Arthritis, run by Assiut University.
Trial summary
To establish a new protocol in order to increase ultrasound diagnostic accuracy of pediatrics presented with signs of septic hip . Read more about this study
- Who is it for?
- Ages 1 week to 15 years
- Conditions the study is for
- Septic Arthritis
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2023to 30 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 week to 15 years
- All sexes
- Child
Study population: Neonates, infants and children presented with suspected septic hip arthritis.
Who may be able to join
- Neonates, infants and children presented with suspected septic hip arthritis.
Who cannot join
- DDH
Trial locations and contacts
No sites are listed yet.
About this study
To establish a new protocol in order to increase ultrasound diagnostic accuracy of pediatrics presented with signs of septic hip .
Read the 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.
- Conditions
- Septic Arthritis
- Being tested
- Ultrasound
- Medical subject headings
- Arthritis, Infectious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start15 Sep 2023 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ArthritisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Khaled Mostafa Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06003374
- Sponsor's protocol ID
- US in pediateric septic hip.
- Status last verified
- Jun 2023
- First submitted
- 17 Dec 2022
- Last updated
- 22 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Hip Ultrasound as Anew Protocol for Septic Hip in Children
- ClinicalTrials.gov ID
- NCT06003374
- Acronym / sponsor ID
- US in pediateric septic hip.
- Conditions
- Septic Arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Sep 2023 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 22 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To establish a new protocol in order to increase ultrasound diagnostic accuracy of pediatrics presented with signs of septic hip .
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 week to 15 years
- Sex
- All
- Age groups
- Child
- Study population
- Neonates, infants and children presented with suspected septic hip arthritis.
Key inclusion criteria (1 listed)
- Neonates, infants and children presented with suspected septic hip arthritis.
Key exclusion criteria (1 listed)
- DDH
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundAt 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. | Device | – |
Primary outcome
To describe the ultrasound abnormalities seen in Patients with septic hip arthritis.
Time frame: Baseline
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Arthritis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dalia khaled Mostafa, Master (01096638658, daliakhaled46@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To describe the ultrasound abnormalities seen in Patients with septic hip arthritis. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.