Comparison of CT Scan Between Patients With Axial Spondyloarthritis and Control Subjects (SPA-THORAX)

December 30, 2024 updated by: Hôpital NOVO

Comparison of CT Scan Aspects of the Manubriosternal Joint 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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:

  1. - 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.
  2. - Study the characteristics of this structural damage in radiographic and non-radiographic axSpA.

Study Type

Observational

Enrollment (Actual)

377

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

  • France
      • Pontoise, France, 95390
        • Rheumatology department - NOVO Hospital - Pontoise site

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 to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients having a Chest CT scan (as part of a conventional hospitalization or Day hospitalization) between 01/01/2015 and 30/10/2022 for a population of patients with radiographic axSpA and a control population free of chronic inflammatory rheumatism

Description

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.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Chest CT scan Patient
Identification of structural damage to the manubriosternal joint (MST) in a population of patients with radiographic axSpA
Other: Chest CT scan
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.
Chest CT scan Control
Identification of structural damage to the manubriosternal joint (MST) in a control population free of chronic inflammatory rheumatism on chest CT.
Other: Chest CT scan
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the end of the study, an average of 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the end of the study, an average of 1 month
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.
At the end of the study, an average of 1 month
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.
At the end of the study, an average of 1 month
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
At the end of the study, an average of 1 month

Collaborators and Investigators

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

Sponsor

Hôpital NOVO

Investigators

  • Principal Investigator: Dr Edouart Pertuiset, Hospital NOVO - Pontoise site

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)

February 9, 2023

Primary Completion (Actual)

December 13, 2024

Study Completion (Actual)

December 13, 2024

Study Registration Dates

First Submitted

March 7, 2023

First Submitted That Met QC Criteria

March 20, 2023

First Posted (Actual)

March 22, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 30, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHRD 2222

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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