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Completed

NCT Number: NCT05779969

Comparison of CT Scan Between Patients With Axial Spondyloarthritis and Control Subjects

The aim of this study is to define structural damage to the manubriosternal joint (MST) in axial spondyloarthritis (axSpA) by comparing its CT scan aspects between a population of patients with radiographic (axSpA) and a control population free of chronic inflammatory rheumatism.

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Key information

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rheumatology department - NOVO Hospital - Pontoise site

Pontoise, 95390, France

About this study

Axial spondyloarthritis (axSpA) is, together with rheumatoid arthritis, one of the 2 major chronic inflammatory rheumatic diseases. While the lumbar spine and sacroiliac joints are at the forefront of the clinic and diagnosis of axSpA, clinical involvement of the rib cage is common and long-standing. It can lead to limitation of thoracic extension and respiratory consequences. Clinical involvement of the anterior chest wall was evaluated in the early 2010s in axSpA, especially in the newer forms.

Several anatomical structures of the thoracic cage can be the cause of pain and among these is the manubriosternal joint (MST). It is known to be a possible site of inflammatory involvement in axSpA and this is well demonstrated by MRI imaging. Bone CT scans allow precise analysis of changes in the MST joint, but unlike MRI, they do not analyse inflammation, which is itself the cause of structural changes. While inflammation is the main cause of pain, structural changes, particularly ankylosis, are the cause of potentially disabling sequelae. To date, there have been no studies of structural damage to the MST joint in patients with axSpA, including the radiographic form. Moreover, little is known about the CT scan data of the MST joint in healthy subjects. Apart from the interest in defining axSpA-related abnormalities for CT scan analysis of the MST joint in general, it is important to know the frequency and types of structural abnormalities of the MST joint in axSpA, not for early diagnosis, but in terms of assessing the severity of the disease.

The investigator's hypothesis is that there are structural abnormalities of the STD joint in the radiographic axSpA, the characteristics, prevalence and relationship to patient and disease characteristics of which must be determined. This should be analysed in the non-radiographic axSpA. This requires comparison with a control population, but as there are no validated criteria for assessing the pathological nature of the STD joint on CT, it is necessary to proceed in 2 steps:

  • - To define the structural damage to the MST joint in radiographic axSpA by comparison with control subjects. This comparison should focus first on the various basic abnormalities known to be present in radiographic axSpA, and in particular in the sacroiliac joints, such as erosions, subchondral bone condensation, pinching of the joint space, and ankylosis, which should be compared to the fusion phenomena described in controls.
  • - Study the characteristics of this structural damage in radiographic and non-radiographic axSpA.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

axSpA population:

  • Adults aged 18 to 69 years,
  • Diagnosis of axSpA according to the ASAS 2009 criteria,
  • Hospitalized in the Rheumatology Department of the NOVO Hospital (Pontoise site) from 01/01/2015 to 30/10/2022 and had a Chest CT scan with images available in the hospital's computer system,
  • Informed of the study and did not object.

Control population:

  • Adults aged 18 to 69 years,
  • Day hospitalization in the pneumology department of the NOVO Hospital (Pontoise site) from 01/01/2015 to 30/10/2022 and having had a lung scan on this occasion,
  • Informed of the study and did not object.

Exclusion criteria

axSpA population:

  • Peripheral spondyloarthritis,
  • Unavailability of chest CT scan images in the hospital computer system,
  • Unknown result of pelvic X-ray.

Control population:

  • Lung cancer or suspected lung cancer
  • Any of the following conditions: spondyloarthritis, rheumatoid arthritis, psoriatic arthritis, SAPHO syndrome, chest wall bone disease, tumour bone disease, severe scoliosis, malformative syndrome
  • History of thoracic trauma or thoracic surgery,
  • Unavailability of chest CT scan images in the hospital computer system.

Treatment and study plan

Chest CT scan

Other

Comparison of structural damage to the manubriosternal joint (MST) between a population of patients with radiographic axSpA and a control population free of chronic inflammatory rheumatism on chest CT.

Primary outcomes

  1. To define the structural damage of the manubriosternal joint (MST) in axSpA by comparing its Chest CT scan aspects between a population of patients with radiographic axSpA and a control population free of chronic inflammatory rheumatism

    Time frame: At the end of the study, an average of 1 month

    Assessment of the various aspects of the manubriosternal joint on the CT scan. These different elements of analysis are grouped in an evaluation grid. Assessment of the various aspects of the manubriosternal joint on the CT scan. These different elements of analysis are grouped in an evaluation grid. The prevalence of each unit anomaly (e.g. "erosions") will be compared between the radiographic axSpA population and the control population.

Secondary outcomes

  1. Determination of the prevalence of structural damage to the manubriosternal joint (MST) in radiographic axSpA by comparing this population with the control population

    Time frame: At the end of the study, an average of 1 month

    Structural damage to the manubriosternal joint will be assessed on the scans by a double radiologist/rheumatologist reading in the different populations using a review grid.

  2. Determination of the prevalence of structural damage to the manubriosternal joint (MST) in non-radiographic axSpA by comparing this population with the control population

    Time frame: At the end of the study, an average of 1 month

    Structural damage to the manubriosternal joint will be assessed on the scans by a double radiologist/rheumatologist reading in the different populations using a review grid.

  3. Determination of the prevalence of structural damage to the manubriosternal joint (MST) between radiographic axSpA and non- radiographic axSpA

    Time frame: At the end of the study, an average of 1 month

    Structural damage to the manubriosternal joint will be assessed on the scans by a double radiologist/rheumatologist reading in the different populations using a review grid.

  4. Search for a significant association between a phenotypic feature of axSpA and the existence of structural damage to the manubriosternal joint (MST)

    Time frame: At the end of the study, an average of 1 month

    The phenotypic character of axSpA is assessed by clinical criteria defined by the rheumatologist

Sponsors and collaborators

Lead sponsor

Hôpital NOVO

Other

Registry information

Official study title

Comparison of CT Scan Aspects of the Manubriosternal Joint Between Patients With Axial Spondyloarthritis and Control Subjects

Acronym: SPA-THORAX

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 22, 2023
Registry last updated
Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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