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

June 16, 2020 updated by: Hamdi Ons, Medical School of Tunisia

Contribution of EOS in the Structural Evaluation of Spondyloarthritis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Spondyloarthritis (SpA) is a chronic inflammatory disease that can affect the sacroiliac joints, the spine and / or the peripheral joints. It is characterized by a progressive and slow evolution over several years with a risk of ankylosis of the spine. It requires long-term follow-up of patients with repeated x-rays to assess structural damage. This repeated and cumulative exposure to radiation ionization puts at risk the radiosensitive organs that are in the field of irradiation.

EOS is a new low dose X-ray system that significantly reduces X-ray doses compared to conventional radiography. This system allows the global assessment of the entire skeleton from head to toe, static spine and lower limbs with the obtaining of two-dimensional images of high quality with the possibility of a three-dimensional reconstruction. Although the benefits of the EOS system are promising with regard to radiation dose reduction, few studies have investigated its use in SpA and little evidence has supported its reliability in assessing the structural damage caused by the disease.

Study Type

Observational

Enrollment (Actual)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
    • Mannouba
      • Tunis, Mannouba, Tunisia, 2010
        • Institut d'orthopédie Kassab

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intermodality agreement
Time Frame: 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
interreader agreement
Time Frame: 3 months
measuring the interreader agreement between the radiologist and the rheumatologist for the assessement of the sacro-iliac joints and the spine
3 months

Collaborators and Investigators

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

Sponsor

Medical School of Tunisia

Collaborators

Institut Kassab d'Orthopédie

Investigators

  • Study Director: Mataallah Kaouther, university hospital lecturer, Institut d'orthopédie Kassab
  • Study Director: Riahi Hend, university hospital lecturer, Institut d'orthopédie Kassab
  • Study Chair: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 1, 2018

Primary Completion (Anticipated)

August 30, 2020

Study Completion (Anticipated)

November 30, 2020

Study Registration Dates

First Submitted

March 3, 2019

First Submitted That Met QC Criteria

March 4, 2019

First Posted (Actual)

March 5, 2019

Study Record Updates

Last Update Posted (Actual)

June 18, 2020

Last Update Submitted That Met QC Criteria

June 16, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Institut d'orthopédie Kassab

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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