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NCT Number: NCT07102862

Altered Hemorology in Adolescent Idıopathic Scoliosis

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.

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Key information

Conditions

Idiopathic Adolescent Scoliosis

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Health Sciences

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Presence of structural scoliosis with a Cobb angle greater than 10°
  • Age between 10 and 18 years

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Plasma viscosity (PV)

    Time frame: At baseline (single time point)

    Measurement of plasma viscosity (mPa·s) using cone-plate viscometry at a shear rate of 450 s-¹.

  2. Whole blood viscosity (WBV)

    Time frame: 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).

  3. Erythrocyte deformability (EImax)

    Time frame: At baseline (single time point)

    Evaluation of erythrocyte elongation index (EImax) using laser-assisted ektacytometry (Lorrca MaxSis).

  4. Erythrocyte deformability (SS1/2)

    Time frame: At baseline (single time point)

    Evaluation of shear stress at half EImax (SS1/2) using laser-assisted ektacytometry (Lorrca MaxSis).

  5. Erythrocyte aggregation (AI and Tr)

    Time frame: At baseline (single time point)

    Measurement of aggregation index (AI) using Lorrca MaxSis at 37°C under standardized conditions.

  6. Erythrocyte aggregation (Tr)

    Time frame: At baseline (single time point)

    Measurement of relaxation time (Tr) using Lorrca MaxSis at 37°C under standardized conditions.

Secondary outcomes

  1. Correlation between Cobb angle and the Plasma viscosity (mPa·s)

    Time frame: At baseline (single time point)

    Plasma viscosity (mPa·s), measured using a cone-plate rotational viscometer at 450 s-¹, and Cobb angle measured in degrees on standing posteroanterior spinal radiographs

  2. Correlation between cervical lordosis angle and the Plasma viscosity (mPa·s)

    Time frame: At baseline (single time point)

    Plasma viscosity (mPa·s), measured using a cone-plate rotational viscometer at 450 s-¹, and cervical lordosis angle measured in degrees on standing lateral spinal radiographs

  3. Correlation between thoracic kyphosis angle and the Plasma viscosity (mPa·s)

    Time frame: At baseline (single time point)

    Plasma viscosity (mPa·s), measured using a cone-plate rotational viscometer at 450 s-¹, and thoracic kyphosis angle measured in degrees on standing lateral spinal radiographs

  4. Correlation between lumbar lordosis angle and the Plasma viscosity (mPa·s)

    Time frame: At baseline (single time point)

    Plasma viscosity (mPa·s), measured using a cone-plate rotational viscometer at 450 s-¹, and lumbar lordosis angle measured in degrees on standing lateral spinal radiographs

  5. Correlation between angle of trunk rotation (ATR) and the Plasma viscosity (mPa·s)

    Time frame: At baseline (single time point)

    Plasma viscosity (mPa·s), measured using a cone-plate rotational viscometer at 450 s-¹, and angle of trunk rotation (ATR) measured with a scoliometer

  6. Correlation between vertebral rotation (Nash-Moe grade) and the Plasma viscosity (mPa·s)

    Time frame: At baseline (single time point)

    Plasma viscosity (mPa·s), measured using a cone-plate rotational viscometer at 450 s-¹, and Vertebral rotation will be assessed using the Nash-Moe grading system on standing posteroanterior spinal radiographs. The Nash-Moe method classifies pedicle asymmetry into 5 grades (Grade 0 to Grade 4), where higher grades indicate increased vertebral rotation.

  7. Correlation between joint hypermobility (Beighton score) and the Plasma viscosity (mPa·s)

    Time frame: At baseline (single time point)

    Plasma viscosity (mPa·s), measured using a cone-plate rotational viscometer at 450 s-¹, and Joint hypermobility will be measured using the Beighton score (0-9 scale), a standardized clinical examination evaluating passive dorsiflexion of the fifth finger, thumb apposition, elbow hyperextension, knee hyperextension, and forward flexion of the trunk. Scores ≥5 will be considered indicative of generalized joint hypermobility.

  8. Correlation between Cobb angle and the Whole blood viscosity (mPa·s)

    Time frame: At baseline (single time point)

    Whole blood viscosity (mPa·s), measured at multiple shear rates (37.5 to 450 s-¹) and Cobb angle measured in degrees on standing posteroanterior spinal radiographs

  9. Correlation between cervical lordosis angle and the Whole blood viscosity (mPa·s)

    Time frame: At baseline (single time point)

    Whole blood viscosity (mPa·s), measured at multiple shear rates (37.5 to 450 s-¹) and cervical lordosis angle measured in degrees on standing lateral spinal radiographs

  10. Correlation between thoracic kyphosis angle and the Whole blood viscosity (mPa·s)

    Time frame: At baseline (single time point)

    Whole blood viscosity (mPa·s), measured at multiple shear rates (37.5 to 450 s-¹) and thoracic kyphosis angle measured in degrees on standing lateral spinal radiographs

  11. Correlation between lumbar lordosis angle and the Whole blood viscosity (mPa·s)

    Time frame: At baseline (single time point)

    Whole blood viscosity (mPa·s), measured at multiple shear rates (37.5 to 450 s-¹), and lumbar lordosis angle measured in degrees on standing lateral spinal radiographs

  12. Correlation between angle of trunk rotation (ATR) and the Whole blood viscosity (mPa·s)

    Time frame: At baseline (single time point)

    Whole blood viscosity (mPa·s), measured at multiple shear rates (37.5 to 450 s-¹), and angle of trunk rotation (ATR) measured with a scoliometer

  13. Correlation between vertebral rotation (Nash-Moe grade) and the Whole blood viscosity (mPa·s)

    Time frame: At baseline (single time point)

    Whole blood viscosity (mPa·s), measured at multiple shear rates (37.5 to 450 s-¹), and Vertebral rotation will be assessed using the Nash-Moe grading system on standing posteroanterior spinal radiographs. The Nash-Moe method classifies pedicle asymmetry into 5 grades (Grade 0 to Grade 4), where higher grades indicate increased vertebral rotation.

  14. Correlation between joint hypermobility (Beighton score) and the Whole blood viscosity (mPa·s)

    Time frame: At baseline (single time point)

    Whole blood viscosity (mPa·s), measured at multiple shear rates (37.5 to 450 s-¹), and Joint hypermobility will be measured using the Beighton score (0-9 scale), a standardized clinical examination evaluating passive dorsiflexion of the fifth finger, thumb apposition, elbow hyperextension, knee hyperextension, and forward flexion of the trunk. Scores ≥5 will be considered indicative of generalized joint hypermobility.

  15. Correlation between Cobb angle and Erythrocyte deformability (EImax)

    Time frame: At baseline (single time point)

    Erythrocyte deformability (EImax), measured using laser-optical ektacytometry (Lorrca MaxSis) and Cobb angle measured in degrees on standing posteroanterior spinal radiographs

  16. Correlation between cervical lordosis angle and Erythrocyte deformability (EImax)

    Time frame: At baseline (single time point)

    Erythrocyte deformability (EImax), measured using laser-optical ektacytometry (Lorrca MaxSis) and cervical lordosis angle measured in degrees on standing lateral spinal radiographs

  17. Correlation between thoracic kyphosis angle and Erythrocyte deformability (EImax)

    Time frame: At baseline (single time point)

    Erythrocyte deformability (EImax), measured using laser-optical ektacytometry (Lorrca MaxSis) and thoracic kyphosis angle measured in degrees on standing lateral spinal radiographs

  18. Correlation between lumbar lordosis angle and Erythrocyte deformability (EImax)

    Time frame: At baseline (single time point)

    Erythrocyte deformability (EImax), measured using laser-optical ektacytometry (Lorrca MaxSis) and lumbar lordosis angle measured in degrees on standing lateral spinal radiographs

  19. Correlation between angle of trunk rotation (ATR) and Erythrocyte deformability (EImax)

    Time frame: At baseline (single time point)

    Erythrocyte deformability (EImax), measured using laser-optical ektacytometry (Lorrca MaxSis) and angle of trunk rotation (ATR) measured with a scoliometer

  20. Correlation between vertebral rotation (Nash-Moe grade) and Erythrocyte deformability (EImax)

    Time frame: At baseline (single time point)

    Erythrocyte deformability (EImax), measured using laser-optical ektacytometry (Lorrca MaxSis) and Vertebral rotation will be assessed using the Nash-Moe grading system on standing posteroanterior spinal radiographs. The Nash-Moe method classifies pedicle asymmetry into 5 grades (Grade 0 to Grade 4), where higher grades indicate increased vertebral rotation.

  21. Correlation between joint hypermobility (Beighton score) and Erythrocyte deformability (EImax)

    Time frame: At baseline (single time point)

    Erythrocyte deformability (EImax), measured using laser-optical ektacytometry (Lorrca MaxSis) and Joint hypermobility will be measured using the Beighton score (0-9 scale), a standardized clinical examination evaluating passive dorsiflexion of the fifth finger, thumb apposition, elbow hyperextension, knee hyperextension, and forward flexion of the trunk. Scores ≥5 will be considered indicative of generalized joint hypermobility.

  22. Correlation between Cobb angle and Erythrocyte deformability (SS1/2)

    Time frame: At baseline (single time point)

    Erythrocyte deformability (SS1/2), measured using laser-optical ektacytometry (Lorrca MaxSis) and Cobb angle measured in degrees on standing posteroanterior spinal radiographs

  23. Correlation between cervical lordosis angle and Erythrocyte deformability (SS1/2)

    Time frame: At baseline (single time point)

    Erythrocyte deformability (SS1/2), measured using laser-optical ektacytometry (Lorrca MaxSis) and cervical lordosis angle measured in degrees on standing lateral spinal radiographs

  24. Correlation between thoracic kyphosis angle and Erythrocyte deformability (SS1/2)

    Time frame: At baseline (single time point)

    Erythrocyte deformability (SS1/2), measured using laser-optical ektacytometry (Lorrca MaxSis) and thoracic kyphosis angle measured in degrees on standing lateral spinal radiographs

  25. Correlation between lumbar lordosis angle and Erythrocyte deformability (SS1/2)

    Time frame: At baseline (single time point)

    Erythrocyte deformability (SS1/2), measured using laser-optical ektacytometry (Lorrca MaxSis) and lumbar lordosis angle measured in degrees on standing lateral spinal radiographs

  26. Correlation between angle of trunk rotation (ATR) and Erythrocyte deformability (SS1/2)

    Time frame: At baseline (single time point)

    Erythrocyte deformability (SS1/2), measured using laser-optical ektacytometry (Lorrca MaxSis) and angle of trunk rotation (ATR) measured with a scoliometer

  27. Correlation between vertebral rotation (Nash-Moe grade) and Erythrocyte deformability (SS1/2)

    Time frame: At baseline (single time point)

    Erythrocyte deformability (SS1/2), measured using laser-optical ektacytometry (Lorrca MaxSis) and Vertebral rotation will be assessed using the Nash-Moe grading system on standing posteroanterior spinal radiographs. The Nash-Moe method classifies pedicle asymmetry into 5 grades (Grade 0 to Grade 4), where higher grades indicate increased vertebral rotation.

  28. Correlation between joint hypermobility (Beighton score) and Erythrocyte deformability (SS1/2)

    Time frame: At baseline (single time point)

    Erythrocyte deformability (SS1/2), measured using laser-optical ektacytometry (Lorrca MaxSis) and Joint hypermobility will be measured using the Beighton score (0-9 scale), a standardized clinical examination evaluating passive dorsiflexion of the fifth finger, thumb apposition, elbow hyperextension, knee hyperextension, and forward flexion of the trunk. Scores ≥5 will be considered indicative of generalized joint hypermobility.

  29. Correlation between Cobb angle and Erythrocyte aggregation (AI)

    Time frame: At baseline (single time point)

    Erythrocyte aggregation (AI), measured using Lorrca MaxSis under standardized conditions at 37°C and Cobb angle measured in degrees on standing posteroanterior spinal radiographs

  30. Correlation between cervical lordosis angle and Erythrocyte aggregation (AI)

    Time frame: At baseline (single time point)

    Erythrocyte aggregation (AI), measured using Lorrca MaxSis under standardized conditions at 37°C and cervical lordosis angle measured in degrees on standing lateral spinal radiographs

  31. Correlation between thoracic kyphosis angle and Erythrocyte aggregation (AI)

    Time frame: At baseline (single time point)

    Erythrocyte aggregation (AI), measured using Lorrca MaxSis under standardized conditions at 37°C and thoracic kyphosis angle measured in degrees on standing lateral spinal radiographs

  32. Correlation between lumbar lordosis angle and Erythrocyte aggregation (AI)

    Time frame: At baseline (single time point)

    Erythrocyte aggregation (AI), measured using Lorrca MaxSis under standardized conditions at 37°C and lumbar lordosis angle measured in degrees on standing lateral spinal radiographs

  33. Correlation between angle of trunk rotation (ATR) and Erythrocyte aggregation (AI)

    Time frame: At baseline (single time point)

    Erythrocyte aggregation (AI), measured using Lorrca MaxSis under standardized conditions at 37°C and angle of trunk rotation (ATR) measured with a scoliometer

  34. Correlation between vertebral rotation (Nash-Moe grade) and Erythrocyte aggregation (AI)

    Time frame: At baseline (single time point)

    Erythrocyte aggregation (AI), measured using Lorrca MaxSis under standardized conditions at 37°C and Vertebral rotation will be assessed using the Nash-Moe grading system on standing posteroanterior spinal radiographs. The Nash-Moe method classifies pedicle asymmetry into 5 grades (Grade 0 to Grade 4), where higher grades indicate increased vertebral rotation.

  35. Correlation between joint hypermobility (Beighton score) and Erythrocyte aggregation (AI)

    Time frame: At baseline (single time point)

    Erythrocyte aggregation (AI), measured using Lorrca MaxSis under standardized conditions at 37°C and joint hypermobility (Beighton score).

  36. Correlation between Cobb angle and Erythrocyte aggregation (Tr)

    Time frame: At baseline (single time point)

    Erythrocyte aggregation (Tr), measured using Lorrca MaxSis under standardized conditions at 37°C and Cobb angle measured in degrees on standing posteroanterior spinal radiographs

  37. Correlation between cervical lordosis angle and Erythrocyte aggregation (Tr)

    Time frame: At baseline (single time point)

    Erythrocyte aggregation (Tr), measured using Lorrca MaxSis under standardized conditions at 37°C and cervical lordosis angle measured in degrees on standing lateral spinal radiographs

  38. Correlation between thoracic kyphosis angle and Erythrocyte aggregation (Tr)

    Time frame: At baseline (single time point)

    Erythrocyte aggregation (Tr), measured using Lorrca MaxSis under standardized conditions at 37°C and thoracic kyphosis angle measured in degrees on standing lateral spinal radiographs

  39. Correlation between lumbar lordosis angle and Erythrocyte aggregation (Tr)

    Time frame: At baseline (single time point)

    Erythrocyte aggregation (Tr), measured using Lorrca MaxSis under standardized conditions at 37°C and lumbar lordosis angle measured in degrees on standing lateral spinal radiographs

  40. Correlation between angle of trunk rotation (ATR) and Erythrocyte aggregation (Tr)

    Time frame: At baseline (single time point)

    Erythrocyte aggregation (Tr), measured using Lorrca MaxSis under standardized conditions at 37°C and angle of trunk rotation (ATR) measured with a scoliometer

  41. Correlation between vertebral rotation (Nash-Moe grade) and Erythrocyte aggregation (Tr)

    Time frame: At baseline (single time point)

    Erythrocyte aggregation (Tr), measured using Lorrca MaxSis under standardized conditions at 37°C and Vertebral rotation will be assessed using the Nash-Moe grading system on standing posteroanterior spinal radiographs. The Nash-Moe method classifies pedicle asymmetry into 5 grades (Grade 0 to Grade 4), where higher grades indicate increased vertebral rotation.

  42. Correlation between joint hypermobility (Beighton score) and Erythrocyte aggregation (Tr)

    Time frame: At baseline (single time point)

    Erythrocyte aggregation (Tr), measured using Lorrca MaxSis under standardized conditions at 37°C and joint hypermobility (Beighton score)

Sponsors and collaborators

Lead sponsor

Fatih Sultan Mehmet Training and Research Hospital

Other

Collaborators

  • Saglik Bilimleri Universitesi

Registry information

Official study title

Unveiling Altered Hemorheology in Adolescent Idiopathic Scoliosis: a Cross-sectional Case-control Study

Acronym: AHIAIS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 5, 2025
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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