Surface Topography and Radiographic Spinal Damage in Radiographic Axial Spondyloarthritis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorAnkara Etlik City Hospital
About this trial
Radiographic axial spondyloarthritis (r-axSpA) causes progressive structural damage of the spine, conventionally quantified on lateral cervical and lumbar radiographs using the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). Repeated radiography entails cumulative radiation exposure, substantial inter-reader variability and low sensitivity in early disease. DIERS Formetric 4D surface topography provides radiation-free three-dimensional modelling of the spine and pelvis. The association between sagittal balance and structural damage has been demonstrated with a radiation-based system (EOS), but whether a radiation-free topographic method reflects the same association has not been investigated.
This single-centre, cross-sectional observational study will enrol 53 adults with r-axSpA fulfilling the ASAS criteria with radiographic sacroiliitis according to the modified New York criteria. At a single study visit, static DIERS Formetric 4D measurements, chest expansion, BASMI, BASDAI, BASFI and ASDAS-CRP are obtained. mSASSS is scored by two independent readers, blinded to clinical and topographic data, on existing lateral cervical and lumbar radiographs obtained within the preceding 12 months; no additional radiographs are performed for the study. The primary analysis is the correlation between total mSASSS and the DIERS fleche cervicale (cervical sagittal anterior displacement).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 to 65 years
Diagnosis of radiographic axial spondyloarthritis fulfilling the ASAS criteria, confirmed by radiographic sacroiliitis according to the modified New York criteria
Able to provide written informed consent and to complete the assessments
Available lateral cervical and lumbar radiographs obtained within the 12 months preceding the DIERS measurement
Disqualifiers
Neurological disease affecting balance, posture or gait (for example Parkinson disease, amyotrophic lateral sclerosis, cerebellar or vestibular disorders, history of stroke)
History of lower extremity joint arthroplasty (hip or knee)
Orthopaedic conditions affecting posture, balance or gait (ununited fracture, previous spinal or lower extremity surgery)
Advanced cardiopulmonary disease, active infection or malignancy
Trial population
Consecutive patients with radiographic axial spondyloarthritis attending the spondyloarthritis outpatient clinic of the Department of Physical Medicine and Rehabilitation, Ankara Etlik City Hospital.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
DIERS Formetric 4D surface topography
Diagnostic testRadiation-free three-dimensional assessment of spinal and pelvic surface topography performed once in standing position. No radiation, no contact, no intervention on treatment.
Treatment groups
53 Participants
are divided into 1 treatment groupGroup A: Radiographic axial spondyloarthritis patients1 intervention
Trial outcomes
Primary outcomes
1
Correlation between total mSASSS and DIERS fleche cervicale
Total modified Stoke Ankylosing Spondylitis Spine Score (mSASSS; range 0 to 72, higher scores indicate greater structural damage), calculated as the mean of two independent blinded readers, correlated with fleche cervicale (cervical sagittal anterior displacement, mm) measured by DIERS Formetric 4D surface topography. Reported as a correlation coefficient with magnitude, direction and 95% confidence interval.
Time frame
Single assessment session (Day 1); mSASSS scored on radiographs obtained within the 12 months preceding the assessmentSecondary outcomes
1
Correlation between total mSASSS and other DIERS Formetric static parameters
Total mSASSS (range 0 to 72, higher scores indicate greater structural damage) correlated with the remaining DIERS Formetric 4D static parameters: sagittal imbalance (mm and degrees), coronal imbalance (mm), pelvic obliquity (mm), pelvic torsion (degrees), cervical depth distance (mm), lumbar depth distance (mm), kyphotic angle (degrees) and lordotic angle (degrees). Reported as correlation coefficients with 95% confidence intervals.
Time frame
Single assessment session (Day 1); mSASSS scored on radiographs obtained within the 12 months preceding the assessment2
Correlation between DIERS sagittal parameters and BASDAI
Bath Ankylosing Spondylitis Disease Activity Index (range 0 to 10, higher scores indicate greater disease activity) correlated with DIERS sagittal parameters.
Time frame
Single assessment session (Day 1)3
Correlation between DIERS sagittal parameters and BASFI
Bath Ankylosing Spondylitis Functional Index (range 0 to 10, higher scores indicate worse physical function) correlated with DIERS Formetric 4D static parameters: fleche cervicale (mm), sagittal imbalance (mm and degrees), coronal imbalance (mm), pelvic obliquity (mm), pelvic torsion (degrees), cervical and lumbar depth distance (mm), kyphotic angle (degrees) and lordotic angle (degrees).
Time frame
Single assessment session (Day 1)4
Correlation between DIERS sagittal parameters and BASMI
Bath Ankylosing Spondylitis Metrology Index (range 0 to 10, higher scores indicate worse spinal mobility) correlated with DIERS Formetric 4D static parameters: fleche cervicale (mm), sagittal imbalance (mm and degrees), coronal imbalance (mm), pelvic obliquity (mm), pelvic torsion (degrees), cervical and lumbar depth distance (mm), kyphotic angle (degrees) and lordotic angle (degrees).
Time frame
Single assessment session (Day 1)Sponsors and contacts
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Source ClinicalTrials.gov