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临床试验/NCT04746508
NCT04746508Unknown不适用

The Influence of Bilateral and Unilateral Flat Foot on Coronal Spinopelvic Alignment in Asymptomatic Young Healthy Males

Hacettepe University1 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
360
试验地点
1
主要终点
Calcaneal pitch angle (CPA)

研究概览

简要总结

This study aimed to present the influence of unilateral and bilateral flat foot on coronal spinopelvic alignment in asymptomatic young healthy males. It will be carried out by examining the medical reports of individuals who apply to the National Health Board to work in positions requiring physical fitness between January 2018 and January 2019. Plain radiographies of the feet, pelvis, and spine will be analyzed. Calcaneal pitch angle (CPA) for flat foot, pelvic obliquity (PO), and Cobb angle (CA) for spinal asymmetry will be measured. After all analyzes were completed, participants will be divided into 2 groups as unilateral (UniFF) or bilateral (BiFF) flat foot, depending on the CPA measurements and will be compared.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Body mass index (BMI) ranging between 18.5-24.9 kg/m2 (accepted as normal weight by World Health Organisation (WHO))
  • Age ranging between 18-25 years
  • Male gender

排除标准

  • Being older than 25 years
  • BMI out of normal weight according to WHO
  • Being female
  • History of spinal trauma/ surgery
  • Having/had spinal disorders like spondylolisthesis, spondylodiscitis, etc.
  • Having/had chronic inflammatory arthritis especially spodiloarthrosis (i.e., ankylosing spondylitis, psoriatic arthritis, etc.)
  • Having/had a vertebral fracture
  • Having/had aseptic necrosis of the vertebra
  • Radiographs with inappropriate image qualities.

结局指标

主要结局

Calcaneal pitch angle (CPA)

时间窗: Baseline

Calcaneal pitch angle (CPA) is defined as an angle between a line drawn from the inferior of the calcaneocuboid joint to the inferior border of the calcaneus and a second line drawn from the inferior aspect of the sesamoid bones to the inferior border (13). CPA for both (right and left) foot was evaluated from all plain radiographs in this study and the angles equal to or less than 20 degrees were accepted as a flat foot.

Pelvic obliquity (PO)

时间窗: Baseline

Pelvic obliquity (PO) was measured by horizontal pelvic obliquity according to Osebold et al. from a posteroanterior radiograph. The angle between the line drawn between the most proximal points on the iliac crest and the line drawn parallel to the lower end of the radiograph was recorded.

The Cobb angle (CA

时间窗: Baseline

The Cobb angle (CA) is a gold standard measurement for identifying the magnitude of spinal curves (14). Spinal curvature was measured from the standing full-length posteroanterior radiograph. The angle of the curve is measured as an angle between the perpendiculars of the lines parallel to the upper border of the upper vertebral body and parallel to the lower border of the lowest vertebral body of the curve (16). Straight or symmetrical spines in the coronal plane were accepted as a normal spine, and curves\<10 degrees accepted as spinal asymmetry, and the curves ≥ 10 degrees accepted as scoliosis (15). Spinal curve patterns in coronal planes were classified according to the Scoliosis Research Society classification. The curve was classified as single in terms of one curve exists in the thoracal or lumbal spine; as double in terms of one curve exist the through thoracal and lumbal spine; and as triple that exists through upper thoracal, middle thoracal and lumbal spine (17).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pınar Kısacık, PhD

Principle Investigator

Hacettepe University

研究点 (1)

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