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

Spondyloarthritis Clinical Trial

Official title:

Contribution of EOS in the Structural Evaluation of Spondyloarthritis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03863756
• Other study ID #: Institut d'orthopédie Kassab
• Status: Active, not recruiting
• Start date: January 1, 2018
• Est. completion date: November 30, 2020

Study information

• Verified date: June 2020
• Source: Medical School of Tunisia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: November 30, 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Spondylarthritis
• Spondyloarthritis

Intervention

Radiation:
• 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

Locations

Country	Name	City	State
Tunisia	Institut d'orthopédie Kassab	Tunis	Mannouba

Sponsors (2)

Lead Sponsor	Collaborator
Medical School of Tunisia	Institut Kassab d'Orthopédie

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	interreader agreement	measuring the interreader agreement between the radiologist and the rheumatologist for the assessement of the sacro-iliac joints and the spine	3 months