Septic ArthritisNCT05780697
Short Term Results of Pediatric Septic Hip Arthritis Management in Assiut University Hospitals
A study testing Surgery of Drainage of septic hip arthritis in people with Septic Arthritis, run by Assiut University.
Trial summary
Detect short term results of pediatric septic hip arthritis and its risk factors Read more about this study
- Who is it for?
- Ages 1 day to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Septic Arthritis
- What is being tested?
- Surgery of Drainage of septic hip arthritis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Mar 2023to Mar 2025
- Phase
- Interventional
- 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 day to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children younger than 14 years old presented with septic hip arthritis only or by bilateral septic hip arthritis in Assiut University Hospitals
Who cannot join
- 1-patients with Tuberculous arthritis 2-patients whose parents refuse to participate in the study
Trial locations and contacts
No sites are listed yet.
About this study
Detect short term results of pediatric septic hip arthritis and its risk factors
Read the 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
- Conditions
- Septic Arthritis
- Being tested
- Surgery of Drainage of septic hip arthritis
- Medical subject headings
- Arthritis, Infectious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery of Drainage of septic hip arthritisProcedure or surgery
Surgery for septic hip arthritis by anterior or lateral approach and inspection of femoral head
| Study group | Role | What they receive |
|---|---|---|
| Children presented with septic hip arthritis in Assiut University Hospitals | Experimental | Surgery of Drainage of pus in septic hip arthritis Receives: Procedure: Surgery of Drainage of septic hip arthritis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Moon's criteria for outcome assessment of hip function
Measured: Baseline
Secondary outcomes (1)
Detection of Complications
Complications such as limb-lenght discrepancy , Avascular necrosis of the femoral head and hip destruction will be documented
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 Mar 2023
- Study startMar 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beshoy Elkess Ibram, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05780697
- Sponsor's protocol ID
- Pediatric Septic Hip arthritis
- Status last verified
- Mar 2023
- First submitted
- 13 Mar 2023
- Last updated
- 22 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 6630490Ilharreborde 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.
PubMed 25553604
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Results of Pediatric Septic Hip Arthritis Management in Assiut University Hospitals
- ClinicalTrials.gov ID
- NCT05780697
- Acronym / sponsor ID
- Pediatric Septic Hip arthritis
- Conditions
- Septic Arthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 22 Mar 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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children presented with septic hip arthritis in Assiut University Hospitals | Experimental | Procedure: Surgery of Drainage of septic hip arthritisSurgery of Drainage of pus in septic hip arthritis |
Who may qualify
- Ages
- 1 day to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children younger than 14 years old presented with septic hip arthritis only or by bilateral septic hip arthritis in Assiut University Hospitals
Key exclusion criteria (1 listed)
- 1-patients with Tuberculous arthritis 2-patients whose parents refuse to participate in the study
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 |
|---|---|---|
| Surgery of Drainage of septic hip arthritisSurgery for septic hip arthritis by anterior or lateral approach and inspection of femoral head | Procedure or surgery | Children presented with septic hip arthritis in Assiut University Hospitals |
Primary outcome
Modified Moon's criteria for outcome assessment of hip function
Time frame: Baseline
1 secondary outcome
Detection of Complications
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Background: PubMed 6630490Fabry 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.
- Background: PubMed 25553604Ilharreborde 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.
- Individual participant dataSharing planned: No
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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?
A study testing Surgery of Drainage of septic hip arthritis in people with 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 Mar 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 Beshoy Elkes Abram, Resident Dr (01284144493, Beshoelghalban_2010@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Moon's criteria for outcome assessment of hip function (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05780697, which also lists 2 linked publications.
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 Mar 2023.