[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658746":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":40,"studyPopulation":41,"armGroups":42,"interventions":48,"overallOfficials":54,"centralContacts":59,"locations":69,"responsibleParty":87,"collaborators":36,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":36,"eligibilityCriteria":96,"healthyVolunteers":92,"sex":97,"minAge":98,"maxAge":99,"enrollmentInfo":100,"targetDuration":36,"studyType":103,"phases":36,"briefSummary":104,"conditions":105,"keywords":109,"overallStatus":72,"whyStopped":36,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Ankara Etlik City Hospital","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":36},[9],{"measure":10,"description":11,"timeFrame":12},"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.","Single assessment session (Day 1); mSASSS scored on radiographs obtained within the 12 months preceding the assessment",[14,17,21,24,27,30,33],{"measure":15,"description":16,"timeFrame":12},"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.",{"measure":18,"description":19,"timeFrame":20},"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.","Single assessment session (Day 1)",{"measure":22,"description":23,"timeFrame":20},"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).",{"measure":25,"description":26,"timeFrame":20},"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).",{"measure":28,"description":29,"timeFrame":20},"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).",{"measure":31,"description":32,"timeFrame":20},"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).",{"measure":34,"description":35,"timeFrame":12},"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.",null,{"allocation":36,"interventionModel":36,"interventionModelDescription":36,"primaryPurpose":36,"observationalModel":38,"timePerspective":39,"maskingInfo":36},"COHORT","CROSS_SECTIONAL","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.\n\nMeasurements: (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).\n\nStatistical 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\\\u003C0.05. Analyses are performed with IBM SPSS version 23 or later.\n\nSample 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.\n\n(2005) for occiput-to-wall distance versus mSASSS, because DIERS parameters are not identical to clinical mobility measures.\n\nReporting follows the STROBE statement.","Consecutive patients with radiographic axial spondyloarthritis attending the spondyloarthritis outpatient clinic of the Department of Physical Medicine and Rehabilitation, Ankara Etlik City Hospital.",[43],{"label":44,"type":36,"description":45,"interventionNames":46},"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.",[47],"Diagnostic Test: DIERS Formetric 4D surface topography",[49],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":36},"DIAGNOSTIC_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.",[44],[55],{"name":56,"affiliation":57,"role":58},"Ajda Bal","Professor of Physical Medicine and Rehabilitation","PRINCIPAL_INVESTIGATOR",[60,65],{"name":61,"role":62,"phone":63,"phoneExt":36,"email":64},"Seyma Alkan, MD","CONTACT","+90 538 337 97 91","symalkan@gmail.com",{"name":66,"role":62,"phone":67,"phoneExt":36,"email":68},"Yasemin Tombak Yildizkan, MD","+90 505 402 97 63","yasemintombak@hotmail.com",[70],{"facility":71,"status":72,"city":73,"state":74,"zip":75,"country":76,"countryCode":36,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"Ankara Etlik City Hospital, Department of Physical Medicine and Rehabilitation","RECRUITING","Ankara","Yenimahalle","06560","Turkey (Türkiye)",{"type":78,"coordinates":79},"Point",[80,81],32.85427,39.91987,{"lat":81,"lon":80},[84],{"name":85,"role":62,"phone":86,"phoneExt":36,"email":64},"Seyma Alkan, Medical Doctor","+90 5383379791",{"type":58,"investigatorFullName":88,"investigatorTitle":89,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"Seyma Alkan","Specialist Physician, Department of Physical Medicine and Rehabilitation, Ankara Etlik City Hospital","100658746","surface-topography-and-radiographic-spinal-damage-in-radiographic-axial-spondyloarthritis-100658746",false,"NCT07855393","Surface Topography and Radiographic Spinal Damage in Radiographic Axial Spondyloarthritis","Association Between Static Spinal Posture Assessed by Surface Topography (DIERS) and Radiographic Structural Damage (mSASSS) in Radiographic Axial Spondyloarthritis: A Cross-Sectional Study","Inclusion Criteria:\n\n* Age 18 to 65 years\n* Diagnosis of radiographic axial spondyloarthritis fulfilling the ASAS criteria, confirmed by radiographic sacroiliitis according to the modified New York criteria\n* Able to provide written informed consent and to complete the assessments\n* Available lateral cervical and lumbar radiographs obtained within the 12 months preceding the DIERS measurement\n\nExclusion Criteria:\n\n* Neurological disease affecting balance, posture or gait (for example Parkinson disease, amyotrophic lateral sclerosis, cerebellar or vestibular disorders, history of stroke)\n* History of lower extremity joint arthroplasty (hip or knee)\n* Orthopaedic conditions affecting posture, balance or gait (ununited fracture, previous spinal or lower extremity surgery)\n* Advanced cardiopulmonary disease, active infection or malignancy\n* Pregnancy","ALL","18 Years","65 Years",{"count":101,"type":102},53,"ESTIMATED","OBSERVATIONAL","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.\n\nThis 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).",[106,107,108],"Axial Spondyloarthritis","Ankylosing Spondylitis","Spondylarthritis",[110,111,112,113,114,115,116,117],"surface topography","rasterstereography","DIERS Formetric","mSASSS","sagittal balance","spinal posture","radiation-free imaging","spinal mobility","2026-09-28",{"date":120,"type":121},"2026-10-02","ACTUAL",{"date":123,"type":121},"2026-09-19",{"date":125,"type":102},"2027-08-20",{"name":5,"class":6},1]