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Surface Topography and Radiographic Spinal Damage in Radiographic Axial Spondyloarthritis

28 september 2026 uppdaterad av: Seyma Alkan, Ankara Etlik City Hospital

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).

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

53

Kontakter och platser

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Studiekontakt

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Studieorter

  • Turkiet (Türkiye)
    • Yenimahalle
      • Ankara, Yenimahalle, Turkiet (Türkiye), 06560
        • Rekrytering
        • Ankara Etlik City Hospital, Department of Physical Medicine and Rehabilitation
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Consecutive patients with radiographic axial spondyloarthritis attending the spondyloarthritis outpatient clinic of the Department of Physical Medicine and Rehabilitation, Ankara Etlik City Hospital.

Beskrivning

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiv: CROSS_SECTIONAL

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
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.
Diagnostiskt test: DIERS Formetric 4D surface topography

Radiation-free three-dimensional assessment of spinal and pelvic surface topography performed once in standing position. No radiation, no contact, no intervention on treatment.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Correlation between total mSASSS and DIERS fleche cervicale
Tidsram: Single assessment session (Day 1); mSASSS scored on radiographs obtained within the 12 months preceding the assessment

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.
Single assessment session (Day 1); mSASSS scored on radiographs obtained within the 12 months preceding the assessment

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Correlation between total mSASSS and other DIERS Formetric static parameters
Tidsram: Single assessment session (Day 1); mSASSS scored on radiographs obtained within the 12 months preceding the assessment

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.
Single assessment session (Day 1); mSASSS scored on radiographs obtained within the 12 months preceding the assessment
Correlation between DIERS sagittal parameters and BASDAI
Tidsram: Single assessment session (Day 1)

Bath Ankylosing Spondylitis Disease Activity Index (range 0 to 10, higher scores indicate greater disease activity) correlated with DIERS sagittal parameters.
Single assessment session (Day 1)
Correlation between DIERS sagittal parameters and BASFI
Tidsram: Single assessment session (Day 1)

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).
Single assessment session (Day 1)
Correlation between DIERS sagittal parameters and BASMI
Tidsram: Single assessment session (Day 1)

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).
Single assessment session (Day 1)
Correlation between DIERS sagittal parameters and ASDAS-CRP
Tidsram: Single assessment session (Day 1)

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).
Single assessment session (Day 1)
Correlation between DIERS sagittal parameters and chest expansion
Tidsram: Single assessment session (Day 1)

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).
Single assessment session (Day 1)
Discriminative performance of DIERS sagittal parameters for mSASSS thresholds
Tidsram: Single assessment session (Day 1); mSASSS scored on radiographs obtained within the 12 months preceding the assessment

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.
Single assessment session (Day 1); mSASSS scored on radiographs obtained within the 12 months preceding the assessment

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Ankara Etlik City Hospital

Utredare

  • Huvudutredare: Ajda Bal, Professor of Physical Medicine and Rehabilitation

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

19 september 2026

Primärt slutförande (Beräknad)

20 juni 2027

Avslutad studie (Beräknad)

20 augusti 2027

Studieregistreringsdatum

Först inskickad

28 september 2026

Först inskickad som uppfyllde QC-kriterierna

28 september 2026

Första postat (Faktisk)

2 oktober 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

2 oktober 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • AEŞH-BADEK1-2026-048

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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.

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