Sensitive Imaging in Ankylosing Spondylitis
- Conditions
- Ankylosing SpondylitisBechterew disease100836241000381610043237
- 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
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.
* > 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
Name Time Method <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
Name Time Method <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>