Status:
COMPLETED
Progression of Spinal Fusion in Ankylosing Spondylitis
Lead Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Ankylosing Spondylitis
Eligibility:
All Genders
18+ years
Brief Summary
This study will evaluate: 1) whether computed tomography (CT) scanning is better than regular x-rays for measuring changes in the stiffness, or fusion, of the spine in patients with ankylosing spondyl...
Detailed Description
Spinal fusion is the clinical, radiological, and pathological hallmark of ankylosing spondylitis (AS). However, spinal fusion occurs slowly in AS. Serial radiographs rarely show changes over 2 years, ...
Eligibility Criteria
Inclusion
- A. LONGITUDINAL STUDY PROTOCOL:
- Fifty-five patients will be studied.
- INCLUSION CRITERIA:
- Age 18 years or older
- Diagnosis of AS by the modified New York criteria
- Lumbar spine BASRI score of 0, 1, 2, or 3
- We will aim to recruit at least 6 patients in each of the following BASRI lumbar spine categories:
- 0 or 1 (normal or suspicious changes)
- 2 (erosions, sclerosis or squaring with or without syndesmophytes or 2 or fewer vertebrae)
- 3 (syndesmophytes on 3 or more vertebrae with fusion of at most 2 vertebrae)
- EXCLUSION CRITERIA:
- Inability to provide informed consent.
- BASRI lumbar spine score of 4 (complete fusion; 12)
- Contraindication to MRI scanning based on the NMR Center MRI Safety Screening Questionnaire or size or weight limitations of the scanner.
- History of allergic reactions to gadolinium-DPTA contrast used for MRI
- Anticipated unavailability for follow-up over 2 years
- Pregnancy
- Onset of AS at age 16 or younger
- Spondyloarthropathy other than AS
- Severe scoliosis or other spinal malalignment that would complicate scan interpretation
- B. CROSS-SECTIONAL (RELIABILITY) STUDY PROTOCOL
- Up to 35 patients will be studied.
- INCLUSION CRITERIA:
- Age 18 years or older
- Diagnosis of AS by the modified New York criteria (5)
- EXCLUSION CRITERIA:
- Inability to provide informed consent
- BASRI lumbar spine score of 4 (complete fusion)\<TAB\>
- Pregnancy
- Onset of AS at age 16 or younger
- Spondyloarthropathy other than AS
- Severe scoliosis or other spinal malalignment that would complicate scan interpretation
Exclusion
Key Trial Info
Start Date :
December 3 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00085995
Start Date
December 3 2004
Last Update
January 5 2026
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892