此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Surface Topography and Radiographic Spinal Damage in Radiographic Axial Spondyloarthritis

2026年11月10日 更新者：Seyma Alkan、Ankara Etlik City Hospital

Association Between Static Spinal Posture Assessed by Surface Topography (DIERS) and Radiographic Structural Damage (Modified Stoke Ankylosing Spondylitis Spine Score, 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 (four-dimensional) surface topography (DIERS International GmbH, Schlangenbad, Germany) 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 biplanar low-dose radiography system (EOS imaging, Paris, France), 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 Assessment of SpondyloArthritis international Society (ASAS) criteria with radiographic sacroiliitis according to the modified New York criteria. At a single study visit, static DIERS Formetric 4D measurements, chest expansion, the Bath Ankylosing Spondylitis Metrology Index (BASMI), the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), the Bath Ankylosing Spondylitis Functional Index (BASFI) and the Ankylosing Spondylitis Disease Activity Score with C-reactive protein (ASDAS-CRP) are obtained. mSASSS is scored by a single reader, 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 flèche cervicale (cervical sagittal anterior displacement).

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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), human leukocyte antigen B27 (HLA-B27) status, current medication category; (c) radiographic sacroiliitis grade according to the modified New York criteria and the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS; range 0 to 72), scored by a single reader blinded to clinical and topographic data; (d) chest expansion; (e) the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), the Bath Ankylosing Spondylitis Functional Index (BASFI) and the Ankylosing Spondylitis Disease Activity Score with C-reactive protein (ASDAS-CRP), the latter using routine C-reactive protein values with no additional blood sampling; (f) Bath Ankylosing Spondylitis Metrology Index (BASMI) total score and its five components; (g) DIERS Formetric 4D (four-dimensional) static parameters: flèche 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 flèche 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 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 Statistics (Statistical Package for the Social Sciences) version 23 or later.

Sample size: calculated with G*Power 3.1.9 for a bivariate normal correlation model, two-tailed, correlation under the null hypothesis (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 Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement.

研究类型

观察性的

注册 (估计的)

53

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 土耳其（türkiye）
    • Yenimahalle
      • Ankara、Yenimahalle、土耳其（türkiye）、06560
        • 招聘中
        • Ankara Etlik City Hospital, Department of Physical Medicine and Rehabilitation
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

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

描述

Inclusion Criteria:

  • Age 18 to 65 years
  • Diagnosis of radiographic axial spondyloarthritis fulfilling the Assessment of SpondyloArthritis international Society (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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 观测模型：CASE_ONLY
  • 时间观点：CROSS_SECTIONAL

队列和干预

团体/队列
干预/治疗
Radiographic axial spondyloarthritis patients

Adults aged 18 to 65 years with radiographic axial spondyloarthritis fulfilling the Assessment of SpondyloArthritis international Society (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, chest expansion and clinical indices: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Metrology Index (BASMI) and Ankylosing Spondylitis Disease Activity Score with C-reactive protein (ASDAS-CRP). The modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) is scored on existing lateral cervical and lumbar radiographs obtained within the preceding 12 months; no additional radiographs are taken.
诊断测试：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Correlation between total mSASSS and DIERS fleche cervicale
大体时间：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), correlated with flèche 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

次要结果测量

结果测量
措施说明
大体时间
Correlation between DIERS sagittal parameters and BASMI
大体时间：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
大体时间：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 total mSASSS and other DIERS Formetric static parameters
大体时间：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) 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
大体时间：Single assessment session (Day 1)

Bath Ankylosing Spondylitis Disease Activity Index (range 0 to 10, higher scores indicate greater disease activity) correlated with DIERS Formetric 4D static parameters: flèche 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 BASFI
大体时间：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: flèche 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
大体时间：Single assessment session (Day 1)

Chest expansion measured in centimetres correlated with DIERS Formetric 4D static parameters: flèche 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
大体时间：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 total modified Stoke Ankylosing Spondylitis Spine Score (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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Ankara Etlik City Hospital

调查人员

  • 首席研究员：Ajda Bal、Professor of Physical Medicine and Rehabilitation

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年9月19日

初级完成 (估计的)

2027年6月20日

研究完成 (估计的)

2027年6月20日

研究注册日期

首次提交

2026年9月28日

首先提交符合 QC 标准的

2026年9月28日

首次发布 (实际的)

2026年10月2日

研究记录更新

最后更新发布 (实际的)

2026年11月12日

上次提交的符合 QC 标准的更新

2026年11月10日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • AEŞH-BADEK1-2026-909

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Individual participant data will not be shared. According to the study protocol, research data are accessible only to the investigators. Aggregate results will be published.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅