Performance of EOS Imaging System in the Assessment of Spondyloarthritis Structural Changes Compared With Standard Radiography

NCT03863756 | Unknown

• 1 other identifier: Institut d'orthopédie Kassab
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Spondyloarthritis is a chronic rheumatic disease that requires prolonged radiographic follow-up. This repetitive exposure to ionizing radiation puts at risk the radiosensitive organs exposed in the field of irradiation. A new low-dose imaging system has emerged. This technique, called EOS, offers the advantage of lower irradiation associated with high images quality. Our goal through this work was to evaluate the reliability of the EOS imaging system compared to conventional radiography in the evaluation of the structural damage of SpA.

Conditions

Spondyloarthritis

Keywords

spondyloarthritis; spine; syndesmophyte; radiography; EOS

Outcome Measures

Primary Outcomes (1)

• Intermodality agreement

  measuring the intermodality agreement between EOS and conventional radiography for the assessment of both the sacro-iliac joints and the spine by using 3 scores: the modified New York criteria, the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) and the Bath Ankylosing Spondylitis Radiology Index (BASRI).

  6 months

Secondary Outcomes (1)

• interreader agreement

  3 months

Interventions

EOS RADIATION

The new EOS-technology (EOS imaging, Paris, France) based on a low-dose X-ray system allows 3D modeling of the spine based on 2-dimensional

Also known as: Standard radiography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

General data demographics , disease characteristics \[symptom duration, disease presentation (axial/peripheral), SpA features (psoriasis, uveitis, Human Leukocyte Antigen(HLA) B27 positivity)\], disease activity: Bath ankylosing spondylitis disease activity index ( BASDAI) and C-reactive protein (CRP) and disease severity:Bath Ankylosing Spondylitis Functional Index (BASFI) data were collected. CR technique: All patients underwent a posteroanterior pelvic CR and a lateral and anteroposterior CR of the full spine. EOS technique: all patients undewent a full spine and pelvis 2D EOS imaging.

You may qualify if:

• Patients with Spondyloarthritis (SpA) meeting the criteria of Amor and / or Assessement of spondyloarthritis International Society (ASAS)
• Indication of standard radiography for the follow-up of the patients.

You may not qualify if:

• the presence of a contraindication to the performance of conventional radiography (CR) or EOS imaging
• any disease affecting cognition
• Patients who have had surgery on the spine and / or hip.

Sponsors & Collaborators

• Faculty of Medicine of Tunis: lead
• Institut Kassab d'Orthopédie: collaborator

Study Sites (1)

Institut d'orthopédie Kassab

Tunis, Mannouba, 2010, Tunisia

Location

Related Publications (1)

• Maatallah K, Hamdi O, Bouaziz M, Lassoued H, Labbene E, Ladeb F, Kaffel D, Riahi H, Hamdi W. EOS: A new tool with weaknesses for assessing structural changes in spondyloarthritis. Joint Bone Spine. 2022 Jul;89(4):105328. doi: 10.1016/j.jbspin.2021.105328. Epub 2021 Dec 11. No abstract available.

  PMID: 34906697 DERIVED

MeSH Terms

Conditions

Spondylarthritis

Condition Hierarchy (Ancestors)

Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Study Officials

• Mataallah Kaouther, university hospital lecturer

  Institut d'orthopédie Kassab

  STUDY DIRECTOR

• Riahi Hend, university hospital lecturer

  Institut d'orthopédie Kassab

  STUDY DIRECTOR

• Hamdi Wafa, University Hospital Professor

  Institut d'orthopédie Kassab

  STUDY CHAIR

• Chelli Mouna, University Hospital Professor

  Institut d'orthopédie Kassab

  STUDY CHAIR

• Kaffel Dhia, Associate professor

  Institut d'orthopédie Kassab

  STUDY CHAIR

• Ferjani Hanene, university hospital lecturer

  Institut d'orthopédie Kassab

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: March 3, 2019
• First Posted: March 5, 2019
• Study Start: January 1, 2018
• Primary Completion: August 30, 2020
• Study Completion: November 30, 2020
• Last Updated: June 18, 2020

Record last verified: 2020-06

Locations

TU (1)