SpondyloarthritisNCT03863756
Performance of EOS Imaging System in the Assessment of Spondyloarthritis Structural Changes Compared With Standard Radiography
An observational study of Spondyloarthritis, run by Faculty of Medicine of Tunis at 1 site in Tunisia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spondyloarthritis
- What is being tested?
- EOS
- Type of treatment
- Surgery or procedure
- How many people
- 75 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Jan 2018to 30 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Spondyloarthritis
- Being tested
- EOS
- Keywords
- spondyloarthritis, spine, syndesmophyte, radiography, EOS
- Medical subject headings
- Spondylarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EOSRadiation
Also called Standard radiography
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Secondary outcomes (1)
interreader agreement
measuring the interreader agreement between the radiologist and the rheumatologist for the assessement of the sacro-iliac joints and the spine
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start1 Jan 2018
- Primary completion30 Aug 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SpondyloarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty of Medicine of Tunis
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Kassab d'Orthopédie
- Responsible party
- Principal investigator, Hamdi Ons, Faculty of Medicine of Tunis
- Investigators
- Mataallah Kaouther, university hospital lecturer, Study director, Institut d'orthopédie KassabRiahi Hend, university hospital lecturer, Study director, Institut d'orthopédie KassabHamdi Wafa, University Hospital Professor, Study chair, Institut d'orthopédie KassabChelli Mouna, University Hospital Professor, Study chair, Institut d'orthopédie KassabKaffel Dhia, Associate professor, Study chair, Institut d'orthopédie KassabFerjani Hanene, university hospital lecturer, Study chair, Institut d'orthopédie Kassab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03863756
- Sponsor's protocol ID
- Institut d'orthopédie Kassab
- Status last verified
- Jun 2020
- First submitted
- 3 Mar 2019
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34906697
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of EOS in the Structural Evaluation of Spondyloarthritis
- ClinicalTrials.gov ID
- NCT03863756
- Acronym / sponsor ID
- Institut d'orthopédie Kassab
- Conditions
- Spondyloarthritis
- Keywords
- spondyloarthritis, spine, syndesmophyte, radiography, EOS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Faculty of Medicine of TunisUniversity, hospital or other
- Collaborators
- Institut Kassab d'Orthopédie
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Aug 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 5 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EOSAlso: Standard radiographyThe 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 | Radiation | – |
Primary outcome
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).
1 secondary outcome
interreader agreement
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
- Derived from this study: PubMed 34906697Maatallah 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mataallah Kaouther, university hospital lecturer study director
Institut d'orthopédie Kassab
Riahi Hend, university hospital lecturer study director
Institut d'orthopédie Kassab
Hamdi Wafa, University Hospital Professor study chair
Institut d'orthopédie Kassab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spondyloarthritis, run by Faculty of Medicine of Tunis at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intermodality agreement (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03863756, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2020.