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

NCT ID: NCT03863756

Last Updated: 2020-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2020-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Spondyloarthritis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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EOS

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

Intervention Type RADIATION

Other Intervention Names

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Standard radiography

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut Kassab d'Orthopédie

OTHER

Sponsor Role collaborator

Faculty of Medicine of Tunis

OTHER

Sponsor Role lead

Responsible Party

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Hamdi Ons

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mataallah Kaouther, university hospital lecturer

Role: STUDY_DIRECTOR

Institut d'orthopédie Kassab

Riahi Hend, university hospital lecturer

Role: STUDY_DIRECTOR

Institut d'orthopédie Kassab

Hamdi Wafa, University Hospital Professor

Role: STUDY_CHAIR

Institut d'orthopédie Kassab

Chelli Mouna, University Hospital Professor

Role: STUDY_CHAIR

Institut d'orthopédie Kassab

Kaffel Dhia, Associate professor

Role: STUDY_CHAIR

Institut d'orthopédie Kassab

Ferjani Hanene, university hospital lecturer

Role: STUDY_CHAIR

Institut d'orthopédie Kassab

Locations

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Institut d'orthopédie Kassab

Tunis, Mannouba, Tunisia

Site Status

Countries

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Tunisia

References

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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.

Reference Type DERIVED
PMID: 34906697 (View on PubMed)

Other Identifiers

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Institut d'orthopédie Kassab

Identifier Type: -

Identifier Source: org_study_id

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