Unveiling Altered Hemorheology in Adolescent Idiopathic Scoliosis: a Cross-sectional Case-control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Whole blood viscosity (WBV)
研究概览
简要总结
This study aims to investigate potential alterations in hemorheological parameters in adolescents with idiopathic scoliosis (AIS) compared to healthy controls. A total of 30 AIS patients and 30 age- and sex-matched healthy individuals will be evaluated through clinical, radiological, and laboratory assessments. Hematocrit, plasma and whole blood viscosity, erythrocyte deformability, and aggregation will be measured. The goal is to determine whether structural spinal deformities in AIS are associated with changes in microcirculatory blood flow properties.
详细描述
Adolescent idiopathic scoliosis (AIS) is the most common type of scoliosis in children and adolescents. Although extensively studied from orthopedic and biomechanical perspectives, its potential systemic effects remain poorly understood. This study is designed to investigate whether AIS is associated with alterations in blood rheology-specifically, changes in viscosity, erythrocyte deformability, and aggregation-which may reflect underlying microcirculatory dysfunction.
Hemorheology refers to the study of blood flow and its mechanical properties. In this study, key hemorheological parameters-including hematocrit (Hct), whole blood viscosity (WBV), plasma viscosity (PV), erythrocyte deformability (ED), and erythrocyte aggregation (EA)-will be assessed in AIS patients and healthy controls. A total of 30 AIS patients and 30 age- and sex-matched healthy participants will be enrolled.
Blood samples will be collected for rheological analysis, and measurements will be performed using a rotational cone-plate viscometer and a laser-optical erythrocyte analyzer under standardized shear conditions. Clinical and radiological data, such as Cobb angle, vertebral rotation, and sagittal alignment, will also be collected. Statistical comparisons between groups and correlation analyses will be conducted to evaluate the relationships between hemorheological variables and scoliosis severity or type.
This study will provide the first controlled assessment of hemorheological behavior in adolescents with idiopathic scoliosis. Results may offer novel insights into whether spinal deformity has systemic circulatory implications and may help identify early markers of microvascular dysfunction associated with AIS.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Presence of structural scoliosis with a Cobb angle greater than 10°
- •Age between 10 and 18 years
排除标准
- •Other types of scoliosis, such as syndromic conditions, congenital vertebral deformities, and neuromuscular scoliosis
- •Presence of any diseases or conditions that may affect hemorheology, such as cardiovascular, respiratory, and hematologic diseases
- •Obesity (Body mass index [BMI] > 30)
- •Being treated surgically for scoliosis
结局指标
主要结局
Whole blood viscosity (WBV)
时间窗: At baseline (single time point)
Measurement of whole blood viscosity (mPa·s) using cone-plate viscometer at multiple shear rates (37.5 to 450 s-¹).
Erythrocyte deformability (EImax)
时间窗: At baseline (single time point)
Evaluation of erythrocyte elongation index (EImax) using laser-assisted ektacytometry (Lorrca MaxSis).
Erythrocyte deformability (SS1/2)
时间窗: At baseline (single time point)
Evaluation of shear stress at half EImax (SS1/2) using laser-assisted ektacytometry (Lorrca MaxSis).
Erythrocyte aggregation (AI and Tr)
时间窗: At baseline (single time point)
Measurement of aggregation index (AI) using Lorrca MaxSis at 37°C under standardized conditions.
Plasma viscosity (PV)
时间窗: At baseline (single time point)
Measurement of plasma viscosity (mPa·s) using cone-plate viscometry at a shear rate of 450 s-¹.
Erythrocyte aggregation (Tr)
时间窗: At baseline (single time point)
Measurement of relaxation time (Tr) using Lorrca MaxSis at 37°C under standardized conditions.
次要结局
- Correlation between Cobb angle and the Plasma viscosity (mPa·s)(At baseline (single time point))
- Correlation between cervical lordosis angle and the Plasma viscosity (mPa·s)(At baseline (single time point))
- Correlation between thoracic kyphosis angle and the Plasma viscosity (mPa·s)(At baseline (single time point))
- Correlation between lumbar lordosis angle and the Plasma viscosity (mPa·s)(At baseline (single time point))
- Correlation between angle of trunk rotation (ATR) and the Plasma viscosity (mPa·s)(At baseline (single time point))
- Correlation between vertebral rotation (Nash-Moe grade) and the Plasma viscosity (mPa·s)(At baseline (single time point))
- Correlation between joint hypermobility (Beighton score) and the Plasma viscosity (mPa·s)(At baseline (single time point))
- Correlation between Cobb angle and the Whole blood viscosity (mPa·s)(At baseline (single time point))
- Correlation between cervical lordosis angle and the Whole blood viscosity (mPa·s)(At baseline (single time point))
- Correlation between thoracic kyphosis angle and the Whole blood viscosity (mPa·s)(At baseline (single time point))
- Correlation between lumbar lordosis angle and the Whole blood viscosity (mPa·s)(At baseline (single time point))
- Correlation between angle of trunk rotation (ATR) and the Whole blood viscosity (mPa·s)(At baseline (single time point))
- Correlation between vertebral rotation (Nash-Moe grade) and the Whole blood viscosity (mPa·s)(At baseline (single time point))
- Correlation between joint hypermobility (Beighton score) and the Whole blood viscosity (mPa·s)(At baseline (single time point))
- Correlation between Cobb angle and Erythrocyte deformability (EImax)(At baseline (single time point))
- Correlation between cervical lordosis angle and Erythrocyte deformability (EImax)(At baseline (single time point))
- Correlation between thoracic kyphosis angle and Erythrocyte deformability (EImax)(At baseline (single time point))
- Correlation between lumbar lordosis angle and Erythrocyte deformability (EImax)(At baseline (single time point))
- Correlation between angle of trunk rotation (ATR) and Erythrocyte deformability (EImax)(At baseline (single time point))
- Correlation between vertebral rotation (Nash-Moe grade) and Erythrocyte deformability (EImax)(At baseline (single time point))
- Correlation between joint hypermobility (Beighton score) and Erythrocyte deformability (EImax)(At baseline (single time point))
- Correlation between Cobb angle and Erythrocyte deformability (SS1/2)(At baseline (single time point))
- Correlation between cervical lordosis angle and Erythrocyte deformability (SS1/2)(At baseline (single time point))
- Correlation between thoracic kyphosis angle and Erythrocyte deformability (SS1/2)(At baseline (single time point))
- Correlation between lumbar lordosis angle and Erythrocyte deformability (SS1/2)(At baseline (single time point))
- Correlation between angle of trunk rotation (ATR) and Erythrocyte deformability (SS1/2)(At baseline (single time point))
- Correlation between vertebral rotation (Nash-Moe grade) and Erythrocyte deformability (SS1/2)(At baseline (single time point))
- Correlation between joint hypermobility (Beighton score) and Erythrocyte deformability (SS1/2)(At baseline (single time point))
- Correlation between Cobb angle and Erythrocyte aggregation (AI)(At baseline (single time point))
- Correlation between cervical lordosis angle and Erythrocyte aggregation (AI)(At baseline (single time point))
- Correlation between thoracic kyphosis angle and Erythrocyte aggregation (AI)(At baseline (single time point))
- Correlation between lumbar lordosis angle and Erythrocyte aggregation (AI)(At baseline (single time point))
- Correlation between angle of trunk rotation (ATR) and Erythrocyte aggregation (AI)(At baseline (single time point))
- Correlation between vertebral rotation (Nash-Moe grade) and Erythrocyte aggregation (AI)(At baseline (single time point))
- Correlation between joint hypermobility (Beighton score) and Erythrocyte aggregation (AI)(At baseline (single time point))
- Correlation between Cobb angle and Erythrocyte aggregation (Tr)(At baseline (single time point))
- Correlation between cervical lordosis angle and Erythrocyte aggregation (Tr)(At baseline (single time point))
- Correlation between thoracic kyphosis angle and Erythrocyte aggregation (Tr)(At baseline (single time point))
- Correlation between lumbar lordosis angle and Erythrocyte aggregation (Tr)(At baseline (single time point))
- Correlation between angle of trunk rotation (ATR) and Erythrocyte aggregation (Tr)(At baseline (single time point))
- Correlation between vertebral rotation (Nash-Moe grade) and Erythrocyte aggregation (Tr)(At baseline (single time point))
- Correlation between joint hypermobility (Beighton score) and Erythrocyte aggregation (Tr)(At baseline (single time point))
研究者
Aslinur Keles Ercisli, MD, PhD
Principal investigator
Fatih Sultan Mehmet Training and Research Hospital