- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05780697
Short Term Results of Pediatric Septic Hip Arthritis Management in Assiut University Hospitals
March 13, 2023 updated by: Beshoy Elkess Ibram, Assiut University
Detect short term results of pediatric septic hip arthritis and its risk factors
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Septic arthritis of the hip is a true orthopedic emergency(1).
In developed countries, the incidence of acute bacterial septic arthritis is estimated to be 4 to 10 per 100,000 children (2).It is caused by many microorganisms.
Staph aureus is most common in children over 2 years of age .
Staph aureus is gram-positive cocci in clusters and most common in nosocomial infections of neonates(3-4).Group B streptococcus is most common in neonates with community-acquired infection and exposed during transvaginal delivery(5).Neisseria gonorrhoeae is gram-negative diplococci and most common in adolescents.when
the causative Organism is Neisseria gonorrhoeae ,patients usually have a preceding migratory polyarthralgia,multiple joint involvement and small red papules(6-7).Group
A beta-hemolytic streptococcus is most common organism following varicella infection.HACEK organisms (Haeophilus,Actinobacillus,Cardiobacterium,Eikenella,and Kingella fastidious) are less common causative organisms(8-9).Early diagnosis and accurate treatment is key in avoiding complications such as joint destruction,joint dislocation , ankylosis, growth arrest or spread of infection leading to osteomyelitis , pelvic abscess or nerve lesions.. Treatment is started without delay after synovial fluid and blood samples have been obtained.
The classical presentation of septic hip arthritis in children is a combination of a painful hip joint with limited range of motion, fever, malaise and inability to bear weight on the affected limb.
Misdiagnosis or inappropriate treatment of acute septic arthritis of the hip in children can result in devastating damage of the joint and possible lifelong disability.
Open arthrotomy , drainage and thorough irrigation of the joint is considered the standard treatment for septic arthritis of the hip.Empiric antibiotic treatment primarily targets S. aureus and takes into account its resistance to antibiotics(10-11).
So,we want to detect short term results of pediatric septic hip arthritis at Assiut University Hospitals
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
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: Beshoy Elkes Abram, Resident Dr
- Phone Number: 01284144493
- Email: Beshoelghalban_2010@yahoo.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
1 day to 14 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Children younger than 14 years old presented with septic hip arthritis only or by bilateral septic hip arthritis in Assiut University Hospitals
Exclusion Criteria:
- 1-patients with Tuberculous arthritis 2-patients whose parents refuse to participate in the study
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
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Children presented with septic hip arthritis in Assiut University Hospitals
Surgery of Drainage of pus in septic hip arthritis
|
Surgery for septic hip arthritis by anterior or lateral approach and inspection of femoral head
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Modified Moon's criteria for outcome assessment of hip function
Time Frame: Baseline
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Detection of Complications
Time Frame: Baseline
|
Complications such as limb-lenght discrepancy , Avascular necrosis of the femoral head and hip destruction will be documented
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Fabry G, Meire E. Septic arthritis of the hip in children: poor results after late and inadequate treatment. J Pediatr Orthop. 1983 Sep;3(4):461-6. doi: 10.1097/01241398-198309000-00008.
- Ilharreborde B. Sequelae of pediatric osteoarticular infection. Orthop Traumatol Surg Res. 2015 Feb;101(1 Suppl):S129-37. doi: 10.1016/j.otsr.2014.07.029. Epub 2014 Dec 29.
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 (Anticipated)
March 1, 2023
Primary Completion (Anticipated)
March 1, 2024
Study Completion (Anticipated)
March 1, 2025
Study Registration Dates
First Submitted
March 13, 2023
First Submitted That Met QC Criteria
March 13, 2023
First Posted (Actual)
March 22, 2023
Study Record Updates
Last Update Posted (Actual)
March 22, 2023
Last Update Submitted That Met QC Criteria
March 13, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pediatric Septic Hip arthritis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
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