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Short Term Results of Pediatric Septic Hip Arthritis Management in Assiut University Hospitals

Primary Purpose

Septic Arthritis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Surgery of Drainage of septic hip arthritis
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Arthritis

Eligibility Criteria

1 Day - 14 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Children presented with septic hip arthritis in Assiut University Hospitals

    Arm Description

    Surgery of Drainage of pus in septic hip arthritis

    Outcomes

    Primary Outcome Measures

    Modified Moon's criteria for outcome assessment of hip function

    Secondary Outcome Measures

    Detection of Complications
    Complications such as limb-lenght discrepancy , Avascular necrosis of the femoral head and hip destruction will be documented

    Full Information

    First Posted
    March 13, 2023
    Last Updated
    March 13, 2023
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05780697
    Brief Title
    Short Term Results of Pediatric Septic Hip Arthritis Management in Assiut University Hospitals
    Official Title
    Short Term Results of Pediatric Septic Hip Arthritis Management in Assiut University Hospitals
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 2023 (Anticipated)
    Primary Completion Date
    March 2024 (Anticipated)
    Study Completion Date
    March 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Detect short term results of pediatric septic hip arthritis and its risk factors
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Septic Arthritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Children presented with septic hip arthritis in Assiut University Hospitals
    Arm Type
    Experimental
    Arm Description
    Surgery of Drainage of pus in septic hip arthritis
    Intervention Type
    Procedure
    Intervention Name(s)
    Surgery of Drainage of septic hip arthritis
    Intervention Description
    Surgery for septic hip arthritis by anterior or lateral approach and inspection of femoral head
    Primary Outcome Measure Information:
    Title
    Modified Moon's criteria for outcome assessment of hip function
    Time Frame
    Baseline
    Secondary Outcome Measure Information:
    Title
    Detection of Complications
    Description
    Complications such as limb-lenght discrepancy , Avascular necrosis of the femoral head and hip destruction will be documented
    Time Frame
    Baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Day
    Maximum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Beshoy Elkes Abram, Resident Dr
    Phone
    01284144493
    Email
    Beshoelghalban_2010@yahoo.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    6630490
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    25553604
    Citation
    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.
    Results Reference
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    Short Term Results of Pediatric Septic Hip Arthritis Management in Assiut University Hospitals

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