Juvenile Idiopathic Arthritis Hiphip indexNCT05206968
Scoring System of Structural Damage for the Hip in Juvenile Idiopathic Arthritis
An observational study of Juvenile Idiopathic Arthritis Hip, run by University Tunis El Manar at 1 site in Tunisia.
Trial summary
Juvenile idiopathic arthritis (JIA) is a chronic inflammatory disease in children affecting mobility and physical function. The hip involvement represents a frequent complication in JIA patients. The assessment of hip damage becomes a mandatory step in disease monitoring. Read more about this study
- Who is it for?
- Ages 4 to 20 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis Hip
- What is being tested?
- pelvic radiograph
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- 1 siteTunisia
- Study dates
- 10 Jan 2022to 31 Mar 2023
- 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 4 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: General data demographics , disease characteristics [symptom duration, disease presentation, JIA subtypes, Antigen(HLA) B27 positivity)], disease activity: Juvenile arthritis disease activity (JADAS), were collected. All patients underwent a posteroanterior pelvic radiograph
Who may be able to join
- All included patient followed the ILAR criteria of JIA and have a hip involvement. This later was defined as the presence of rang motion limitation, and abnormal findings in pelvic radiographic, or ultrasound or MRI in the coxo-femoral joint.
Who cannot join
- The presence of a contraindication to the performance of conventional radiography any disease affecting cognition Patients who have had surgery on the hip
Trial locations and contacts
1 site in 1 country.
Tunisia1 site, 1 recruiting
- Recruiting
Kassab institute of orthopedics
Manouba, 2010
Hanène Lassoued Ferjani, 97950842, lassouedferjanihanene@gmail.com
About this study
Juvenile idiopathic arthritis (JIA) is a chronic inflammatory disease in children affecting mobility and physical function. The hip involvement represents a frequent complication in JIA patients. The assessment of hip damage becomes a mandatory step in disease monitoring. However, radiological scoring was not standardized. This study aimed to compare the two scoring systems previously proposed, examine their repeatability and their intra and inter agreement.
- Conditions
- Juvenile Idiopathic Arthritis Hip
- Being tested
- pelvic radiograph
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pelvic radiographRadiation
Patients with hip involvement underwent a pelvic radiograph
What is being measured
The primary outcome is the main question the study is designed to answer.
intermodality agreement
mesuring the intermodality agreement between two scoring system: the The Childhood Arthritis Radiographic Score of the Hip (CARSH) and the new radiographic scoring system for growth abnormalities and structural change in children with juvenile idiopathic arthritis of the hip
Measured: 6 months
Secondary outcomes (1)
interreader agreement
mesuring the interreader agreement between two experimented pediatric rheumatologist for the assessement of structurla damage in JIA hip
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start10 Jan 2022
- Primary completion30 Oct 2022 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Juvenile Idiopathic Arthritis HipStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, lassoued ferjani Hanene, University Tunis El Manar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05206968
- Sponsor's protocol ID
- 5981
- Acronym
- hip index
- Status last verified
- Jan 2022
- First submitted
- 12 Jan 2022
- Last updated
- 25 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Maatallah K, Lassoued Ferjani H, Ben Nessib D, Dghaies A, Kharrat L, Majdoub F, Kaffel D, Hamdi W. Can pediatric rheumatologists apply available hip scoring systems in daily practice for juvenile idiopathic arthritis? Front Pediatr. 2025 Mar 28;13:1436200. doi: 10.3389/fped.2025.1436200. eCollection 2025.
PubMed 40224384
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scoring System of Structural Damage for the Hip in Juvenile Idiopathic Arthritis
- ClinicalTrials.gov ID
- NCT05206968
- Acronym / sponsor ID
- hip index / 5981
- Conditions
- Juvenile Idiopathic Arthritis Hip
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 30 Oct 2022 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 25 Jan 2022 (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.
Juvenile idiopathic arthritis (JIA) is a chronic inflammatory disease in children affecting mobility and physical function. The hip involvement represents a frequent complication in JIA patients. The assessment of hip damage becomes a mandatory step in disease monitoring. However, radiological scoring was not standardized. This study aimed to compare the two scoring systems previously proposed, examine their repeatability and their intra and inter agreement.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 4 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- General data demographics , disease characteristics [symptom duration, disease presentation, JIA subtypes, Antigen(HLA) B27 positivity)], disease activity: Juvenile arthritis disease activity (JADAS), were collected. All patients underwent a posteroanterior pelvic radiograph
Key inclusion criteria (1 listed)
- All included patient followed the ILAR criteria of JIA and have a hip involvement. This later was defined as the presence of rang motion limitation, and abnormal findings in pelvic radiographic, or ultrasound or MRI in the coxo-femoral joint.
Key exclusion criteria (1 listed)
- The presence of a contraindication to the performance of conventional radiography any disease affecting cognition Patients who have had surgery on the hip
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 |
|---|---|---|
| pelvic radiographPatients with hip involvement underwent a pelvic radiograph | Radiation | – |
Primary outcome
intermodality agreement
Time frame: 6 months
mesuring the intermodality agreement between two scoring system: the The Childhood Arthritis Radiographic Score of the Hip (CARSH) and the new radiographic scoring system for growth abnormalities and structural change in children with juvenile idiopathic arthritis of the hip
1 secondary outcome
interreader agreement
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
- Derived from this study: PubMed 40224384Maatallah K, Lassoued Ferjani H, Ben Nessib D, Dghaies A, Kharrat L, Majdoub F, Kaffel D, Hamdi W. Can pediatric rheumatologists apply available hip scoring systems in daily practice for juvenile idiopathic arthritis? Front Pediatr. 2025 Mar 28;13:1436200. doi: 10.3389/fped.2025.1436200. eCollection 2025.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Juvenile Idiopathic Arthritis Hip, run by University Tunis El Manar at 1 site in Tunisia.
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 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Hanène Lassoued Ferjani, assistant professor (97950842, lassouedferjanihanene@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intermodality agreement (time frame: 6 months). 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 NCT05206968, which also lists 1 linked publication.
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 25 Jan 2022.