Axial SpondyloarthritisNCT07855393
Surface Topography and Radiographic Spinal Damage in Radiographic Axial Spondyloarthritis
An observational study of Axial Spondyloarthritis and Ankylosing Spondylitis, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Axial Spondyloarthritis, Ankylosing Spondylitis, Spondylarthritis
- What is being tested?
- DIERS Formetric 4D surface topography
- How many people
- 53 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Sep 2026to 20 Aug 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients with radiographic axial spondyloarthritis attending the spondyloarthritis outpatient clinic of the Department of Physical Medicine and Rehabilitation, Ankara Etlik City Hospital.
Who may be able to join
- 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
Who cannot join
- 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
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Etlik City Hospital, Department of Physical Medicine and Rehabilitation
Ankara, Yenimahalle, 06560
Seyma Alkan, Medical Doctor, +90 5383379791, symalkan@gmail.com
About this study
Official title: Association Between Static Spinal Posture Assessed by Surface Topography (DIERS) and Radiographic Structural Damage (mSASSS) in Radiographic Axial Spondyloarthritis: A Cross-Sectional Study
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).
Read the detailed description
Design: single-centre, cross-sectional, non-interventional correlation study in a single patient group; no control group. All participant data are collected in one assessment session lasting approximately 45 to 60 minutes.
Measurements: (a) demographic and anthropometric data; (b) disease duration, age at symptom onset, comorbidities, extra-articular involvement (uveitis, inflammatory bowel disease, psoriasis), HLA-B27 status, current medication category; (c) radiographic sacroiliitis grade according to the modified New York criteria and mSASSS (range 0 to 72), scored independently by two blinded readers with inter-reader agreement reported as the intraclass correlation coefficient; (d) chest expansion; (e) BASDAI, BASFI and ASDAS-CRP, the latter using routine C-reactive protein values with no additional blood sampling; (f) BASMI total score and its five components; (g) DIERS Formetric 4D static parameters: fleche cervicale (cervical sagittal anterior displacement, 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).
Statistical analysis: distribution is assessed with the Shapiro-Wilk test. The primary analysis is a Pearson or Spearman correlation between total mSASSS and fleche cervicale, reported with effect size and 95% confidence interval, followed by multiple linear regression adjusted for age and disease duration. Secondary analyses comprise correlations of DIERS parameters with clinical indices and an exploratory receiver operating characteristic analysis of the ability of DIERS sagittal parameters to predict prespecified mSASSS thresholds. The Benjamini-Hochberg procedure is applied to correct for multiple comparisons. Significance is set at p<0.05. Analyses are performed with IBM SPSS version 23 or later.
Sample size: calculated with G*Power 3.1.9 for a bivariate normal correlation model, two-tailed, rho H0 = 0, expected effect size r = 0.40, alpha = 0.05 and power = 0.85, giving a required sample of 53 participants (actual power 0.857). The effect size was set conservatively at r = 0.40 rather than the r = 0.61 reported by Wanders et al.
(2005) for occiput-to-wall distance versus mSASSS, because DIERS parameters are not identical to clinical mobility measures.
Reporting follows the STROBE statement.
- Being tested
- DIERS Formetric 4D surface topography
- Keywords
- surface topography, rasterstereography, DIERS Formetric, mSASSS, sagittal balance, spinal posture, radiation-free imaging, spinal mobility
- Medical subject headings
- Axial Spondyloarthritis, Spondylitis, Ankylosing, Spondylarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIERS Formetric 4D surface topographyDiagnostic test
Radiation-free three-dimensional assessment of spinal and pelvic surface topography performed once in standing position. No radiation, no contact, no intervention on treatment.
| Study group | Role | What they receive |
|---|---|---|
| Radiographic axial spondyloarthritis patients | Adults aged 18 to 65 years with radiographic axial spondyloarthritis fulfilling the ASAS classification criteria with radiographic sacroiliitis according to the modified New York criteria, attending the spondyloarthritis outpatient clinic. All participants undergo a single assessment session including static DIERS Formetric 4D surface topography, clinical indices (BASDAI, BASFI, BASMI, ASDAS-CRP) and chest expansion. mSASSS is scored on existing lateral cervical and lumbar radiographs obtained within the preceding 12 months; no additional radiographs are taken. Receives: Diagnostic Test: DIERS Formetric 4D surface topography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Single assessment session (Day 1); mSASSS scored on radiographs obtained within the 12 months preceding the assessment
Secondary outcomes (7)
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.
Measured: Single assessment session (Day 1); mSASSS scored on radiographs obtained within the 12 months preceding the assessment
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.
Measured: Single assessment session (Day 1)
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).
Measured: Single assessment session (Day 1)
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).
Measured: Single assessment session (Day 1)
Correlation between DIERS sagittal parameters and ASDAS-CRP
Ankylosing Spondylitis Disease Activity Score with C-reactive protein (higher scores indicate greater disease activity) 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).
Measured: Single assessment session (Day 1)
Correlation between DIERS sagittal parameters and chest expansion
Chest expansion measured in centimetres 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).
Measured: Single assessment session (Day 1)
Discriminative performance of DIERS sagittal parameters for mSASSS thresholds
Exploratory receiver operating characteristic analysis of DIERS Formetric 4D sagittal parameters for discriminating prespecified total mSASSS thresholds. Reported as area under the curve with 95% confidence interval, sensitivity and specificity.
Measured: Single assessment session (Day 1); mSASSS scored on radiographs obtained within the 12 months preceding the assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start19 Sep 2026
- Primary completion20 Jun 2027 (estimated)
- Study completion20 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Axial SpondyloarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Seyma Alkan, Ankara Etlik City Hospital
- Investigators
- Ajda Bal, Principal investigator, Professor of Physical Medicine and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855393
- Sponsor's protocol ID
- AEŞH-BADEK1-2026-048
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. According to the approved protocol, research data are accessible only to the investigators. Aggregate results will be published.
Publications
Oliveira TL, Silva FD, Filho AGO, Nico MAC, Fernandes ARC, Ramiro S, Pinheiro MM. Relationship between spinal structural damage and sagittal balance in axial spondyloarthritis: Is the thoracic spine the starting point? Semin Arthritis Rheum. 2024 Apr;65:152415. doi: 10.1016/j.semarthrit.2024.152415. Epub 2024 Feb 7.
PubMed 38340611Wanders A, Landewe R, Dougados M, Mielants H, van der Linden S, van der Heijde D. Association between radiographic damage of the spine and spinal mobility for individual patients with ankylosing spondylitis: can assessment of spinal mobility be a proxy for radiographic evaluation? Ann Rheum Dis. 2005 Jul;64(7):988-94. doi: 10.1136/ard.2004.029728.
PubMed 15958757Turk E, Yurdakul FG, Guler T, Bodur H. Posture, balance and gait in axial spondyloarthritis: a case-control study. Rheumatol Int. 2024 Nov;44(11):2527-2538. doi: 10.1007/s00296-024-05710-5. Epub 2024 Sep 4.
PubMed 39230687