Scoring System of Structural Damage for the Hip in Juvenile Idiopathic Arthritis (hip index)

January 12, 2022 updated by: lassoued ferjani Hanene, University Tunis El Manar
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

45

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

Study Locations

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

4 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • The presence of a contraindication to the performance of conventional radiography any disease affecting cognition Patients who have had surgery on the hip

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
interreader agreement
Time Frame: 3 months
mesuring the interreader agreement between two experimented pediatric rheumatologist for the assessement of structurla damage in JIA hip
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Tunis El Manar

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 (Actual)

January 10, 2022

Primary Completion (Anticipated)

October 30, 2022

Study Completion (Anticipated)

March 31, 2023

Study Registration Dates

First Submitted

January 12, 2022

First Submitted That Met QC Criteria

January 12, 2022

First Posted (Actual)

January 25, 2022

Study Record Updates

Last Update Posted (Actual)

January 25, 2022

Last Update Submitted That Met QC Criteria

January 12, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5981

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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