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

• Sponsor: University Tunis El Manar (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05206968
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Anticipated Duration (Months): 14.6
• Patients Per Site Per Month: 3.1

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Juvenile Idiopathic Arthritis Hip	Radiation: pelvic radiograph

Study Design

• Study Type: Observational
• Anticipated Enrollment: 45 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Scoring System of Structural Damage for the Hip in Juvenile Idiopathic Arthritis
• Actual Study Start Date: Jan 10, 2022
• Anticipated Primary Completion Date: Oct 30, 2022
• Anticipated Study Completion Date: Mar 31, 2023

Outcome Measures

Primary Outcome Measures

1. intermodality agreement [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

Secondary Outcome Measures

1. interreader agreement [3 months]

   mesuring the interreader agreement between two experimented pediatric rheumatologist for the assessement of structurla damage in JIA hip

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 20 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kassab institute of orthopedics	Manouba		Tunisia	2010

Sponsors and Collaborators

• University Tunis El Manar

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: lassoued ferjani Hanene, Assistant professor, University Tunis El Manar
• ClinicalTrials.gov Identifier: NCT05206968
• Other Study ID Numbers: 5981
• First Posted: Jan 25, 2022
• Last Update Posted: Jan 25, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Arthritis; Arthritis, Juvenile

Study Results

No Results Posted as of Jan 25, 2022