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Sensitive Imaging in Ankylosing Spondylitis

Completed
Conditions
Ankylosing Spondylitis
Bechterew disease
10083624
10003816
10043237
Registration Number
NL-OMON39151
Lead Sponsor
eids Universitair Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
40
Inclusion Criteria

a) Male and female patients of at least 18 years having Ankylosing Spondylitis (AS) fulfilling the Modified New York criteria, in which a patient has *definite* AS if the radiological criterion is associated with at least one clinical criterion: ;Clinical criterions:
* low back pain and stiffness for more than 3 months that improves with exercise, but is not relieved by rest.
* limitation of motion of the lumbar spine in the sagittal and frontal planes.
* limitation of chest expansion relative to normal values correlated for age and sex.;Radiological criterion (sacroiliitis grade >= 2 bilaterally or grade 3-4 unilaterally)
* grade 0 = no sacroiliitis
* grade 1 = blurring of the joint margins (*suspicious*)
* grade 2 = sclerosis, erosions, no changes in joint space
* grade 3 = erosions, changes in joint space, partial ankylosis
* grade 4 = complete ankylosis;b) Patients should have at least one syndesmophyte in either the cervical or lumbar spine radiograph at baseline conventional radiography. The maximum number of VUs is 9 (out of 12). ;c) The patient should have given written informed consent.

Exclusion Criteria

* > 9 by syndesmophytes affected vertebral units.;* A history of alcoholism, drug abuse, psychological or other emotional problems, severe comorbidity likely to invalidate informed consent or limit the ability of the subject to comply with the protocol requirements.;* Routine MRI-contraindications (e.g. instable metal implants, pacemaker/ICD, vascular clips, hearing aids and claustrophobia).;* Pregnancy.

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>To study whether there is a relationship between local inflammation and the<br /><br>development of new syndesmophytes at the same site in a vertebral unit in<br /><br>patients with ankylosing spondylitis:<br /><br>• Direct causal relationship: local inflammation * syndesmophyte formation<br /><br>• Indirect causal relationship: inflammation * local changes * resolved<br /><br>inflammation * syndesmophyte formation </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>• To examine the time order of pathologic changes (e.g. inflammation, fatty<br /><br>degeneration, erosion, syndesmophyte formation).<br /><br>• To examine the exact location of inflammation in a vertebral unit.<br /><br>• To test the hypothesis that syndesmophyte formation occurs at sites with<br /><br>complete normal anatomy without inflammation.<br /><br>• To assess the agreement between 3 and 7 Tesla MRI in detecting sites of<br /><br>inflammation<br /><br>• To assess the agreement between CT and conventional radiography of the<br /><br>cervical and lumbar spine in detecting structural changes.<br /><br>• To examine if the thoracic spine provides different information compared to<br /><br>the cervical and lumbar spine.</p><br>
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