Idiopathic Adolescent ScoliosisAHIAISNCT07102862
Altered Hemorology in Adolescent Idıopathic Scoliosis
An observational study of Idiopathic Adolescent Scoliosis, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Adolescent Scoliosis
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Apr 2024to 7 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: This case-control study occurred at the University of Health Sciences in Istanbul from January to May 2025. Participation was voluntary, and written informed consent was obtained from both the adolescents and their legal guardians prior to data collection. Adolescents with idiopathic scoliosis will initially be recruited. An equal number of age-matched and sex-matched healthy controls will also be included. All participants will undergo the same evaluation protocol, and inclusion/exclusion criteria will be applied consistently across both groups.
Who may be able to join
- Presence of structural scoliosis with a Cobb angle greater than 10°
- Age between 10 and 18 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Unveiling Altered Hemorheology in Adolescent Idiopathic Scoliosis: a Cross-sectional Case-control Study
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.
Read the detailed description
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.
- Conditions
- Idiopathic Adolescent Scoliosis
- Keywords
- Idiopathic Adolescent Scoliosis, hemorheology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | 10-18 years old AIS patients | |
| Control Healthy Subjects | Sex and aged match healthy subjecyts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma viscosity (PV)
Measurement of plasma viscosity (mPa·s) using cone-plate viscometry at a shear rate of 450 s-¹.
Measured: At baseline (single time point)
Whole blood viscosity (WBV)
Measurement of whole blood viscosity (mPa·s) using cone-plate viscometer at multiple shear rates (37.5 to 450 s-¹).
Measured: At baseline (single time point)
Erythrocyte deformability (EImax)
Evaluation of erythrocyte elongation index (EImax) using laser-assisted ektacytometry (Lorrca MaxSis).
Measured: At baseline (single time point)
Erythrocyte deformability (SS1/2)
Evaluation of shear stress at half EImax (SS1/2) using laser-assisted ektacytometry (Lorrca MaxSis).
Measured: At baseline (single time point)
Erythrocyte aggregation (AI and Tr)
Measurement of aggregation index (AI) using Lorrca MaxSis at 37°C under standardized conditions.
Measured: At baseline (single time point)
Erythrocyte aggregation (Tr)
Measurement of relaxation time (Tr) using Lorrca MaxSis at 37°C under standardized conditions.
Measured: At baseline (single time point)
Secondary outcomes (42)
Correlation between Cobb angle and the Plasma viscosity (mPa·s)
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
Measured: At baseline (single time point)
Correlation between cervical lordosis angle and the Plasma viscosity (mPa·s)
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
Measured: At baseline (single time point)
Correlation between thoracic kyphosis angle and the Plasma viscosity (mPa·s)
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
Measured: At baseline (single time point)
Correlation between lumbar lordosis angle and the Plasma viscosity (mPa·s)
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
Measured: At baseline (single time point)
Correlation between angle of trunk rotation (ATR) and the Plasma viscosity (mPa·s)
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
Measured: At baseline (single time point)
Correlation between vertebral rotation (Nash-Moe grade) and the Plasma viscosity (mPa·s)
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.
Measured: At baseline (single time point)
Correlation between joint hypermobility (Beighton score) and the Plasma viscosity (mPa·s)
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.
Measured: At baseline (single time point)
Correlation between Cobb angle and the Whole blood viscosity (mPa·s)
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
Measured: At baseline (single time point)
Correlation between cervical lordosis angle and the Whole blood viscosity (mPa·s)
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
Measured: At baseline (single time point)
Correlation between thoracic kyphosis angle and the Whole blood viscosity (mPa·s)
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
Measured: At baseline (single time point)
Correlation between lumbar lordosis angle and the Whole blood viscosity (mPa·s)
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
Measured: At baseline (single time point)
Correlation between angle of trunk rotation (ATR) and the Whole blood viscosity (mPa·s)
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
Measured: At baseline (single time point)
Correlation between vertebral rotation (Nash-Moe grade) and the Whole blood viscosity (mPa·s)
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.
Measured: At baseline (single time point)
Correlation between joint hypermobility (Beighton score) and the Whole blood viscosity (mPa·s)
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.
Measured: At baseline (single time point)
Correlation between Cobb angle and Erythrocyte deformability (EImax)
Erythrocyte deformability (EImax), measured using laser-optical ektacytometry (Lorrca MaxSis) and Cobb angle measured in degrees on standing posteroanterior spinal radiographs
Measured: At baseline (single time point)
Correlation between cervical lordosis angle and Erythrocyte deformability (EImax)
Erythrocyte deformability (EImax), measured using laser-optical ektacytometry (Lorrca MaxSis) and cervical lordosis angle measured in degrees on standing lateral spinal radiographs
Measured: At baseline (single time point)
Correlation between thoracic kyphosis angle and Erythrocyte deformability (EImax)
Erythrocyte deformability (EImax), measured using laser-optical ektacytometry (Lorrca MaxSis) and thoracic kyphosis angle measured in degrees on standing lateral spinal radiographs
Measured: At baseline (single time point)
Correlation between lumbar lordosis angle and Erythrocyte deformability (EImax)
Erythrocyte deformability (EImax), measured using laser-optical ektacytometry (Lorrca MaxSis) and lumbar lordosis angle measured in degrees on standing lateral spinal radiographs
Measured: At baseline (single time point)
Correlation between angle of trunk rotation (ATR) and Erythrocyte deformability (EImax)
Erythrocyte deformability (EImax), measured using laser-optical ektacytometry (Lorrca MaxSis) and angle of trunk rotation (ATR) measured with a scoliometer
Measured: At baseline (single time point)
Correlation between vertebral rotation (Nash-Moe grade) and Erythrocyte deformability (EImax)
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.
Measured: At baseline (single time point)
Correlation between joint hypermobility (Beighton score) and Erythrocyte deformability (EImax)
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.
Measured: At baseline (single time point)
Correlation between Cobb angle and Erythrocyte deformability (SS1/2)
Erythrocyte deformability (SS1/2), measured using laser-optical ektacytometry (Lorrca MaxSis) and Cobb angle measured in degrees on standing posteroanterior spinal radiographs
Measured: At baseline (single time point)
Correlation between cervical lordosis angle and Erythrocyte deformability (SS1/2)
Erythrocyte deformability (SS1/2), measured using laser-optical ektacytometry (Lorrca MaxSis) and cervical lordosis angle measured in degrees on standing lateral spinal radiographs
Measured: At baseline (single time point)
Correlation between thoracic kyphosis angle and Erythrocyte deformability (SS1/2)
Erythrocyte deformability (SS1/2), measured using laser-optical ektacytometry (Lorrca MaxSis) and thoracic kyphosis angle measured in degrees on standing lateral spinal radiographs
Measured: At baseline (single time point)
Correlation between lumbar lordosis angle and Erythrocyte deformability (SS1/2)
Erythrocyte deformability (SS1/2), measured using laser-optical ektacytometry (Lorrca MaxSis) and lumbar lordosis angle measured in degrees on standing lateral spinal radiographs
Measured: At baseline (single time point)
Correlation between angle of trunk rotation (ATR) and Erythrocyte deformability (SS1/2)
Erythrocyte deformability (SS1/2), measured using laser-optical ektacytometry (Lorrca MaxSis) and angle of trunk rotation (ATR) measured with a scoliometer
Measured: At baseline (single time point)
Correlation between vertebral rotation (Nash-Moe grade) and Erythrocyte deformability (SS1/2)
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.
Measured: At baseline (single time point)
Correlation between joint hypermobility (Beighton score) and Erythrocyte deformability (SS1/2)
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.
Measured: At baseline (single time point)
Correlation between Cobb angle and Erythrocyte aggregation (AI)
Erythrocyte aggregation (AI), measured using Lorrca MaxSis under standardized conditions at 37°C and Cobb angle measured in degrees on standing posteroanterior spinal radiographs
Measured: At baseline (single time point)
Correlation between cervical lordosis angle and Erythrocyte aggregation (AI)
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
Measured: At baseline (single time point)
Correlation between thoracic kyphosis angle and Erythrocyte aggregation (AI)
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
Measured: At baseline (single time point)
Correlation between lumbar lordosis angle and Erythrocyte aggregation (AI)
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
Measured: At baseline (single time point)
Correlation between angle of trunk rotation (ATR) and Erythrocyte aggregation (AI)
Erythrocyte aggregation (AI), measured using Lorrca MaxSis under standardized conditions at 37°C and angle of trunk rotation (ATR) measured with a scoliometer
Measured: At baseline (single time point)
Correlation between vertebral rotation (Nash-Moe grade) and Erythrocyte aggregation (AI)
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.
Measured: At baseline (single time point)
Correlation between joint hypermobility (Beighton score) and Erythrocyte aggregation (AI)
Erythrocyte aggregation (AI), measured using Lorrca MaxSis under standardized conditions at 37°C and joint hypermobility (Beighton score).
Measured: At baseline (single time point)
Correlation between Cobb angle and Erythrocyte aggregation (Tr)
Erythrocyte aggregation (Tr), measured using Lorrca MaxSis under standardized conditions at 37°C and Cobb angle measured in degrees on standing posteroanterior spinal radiographs
Measured: At baseline (single time point)
Correlation between cervical lordosis angle and Erythrocyte aggregation (Tr)
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
Measured: At baseline (single time point)
Correlation between thoracic kyphosis angle and Erythrocyte aggregation (Tr)
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
Measured: At baseline (single time point)
Correlation between lumbar lordosis angle and Erythrocyte aggregation (Tr)
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
Measured: At baseline (single time point)
Correlation between angle of trunk rotation (ATR) and Erythrocyte aggregation (Tr)
Erythrocyte aggregation (Tr), measured using Lorrca MaxSis under standardized conditions at 37°C and angle of trunk rotation (ATR) measured with a scoliometer
Measured: At baseline (single time point)
Correlation between vertebral rotation (Nash-Moe grade) and Erythrocyte aggregation (Tr)
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.
Measured: At baseline (single time point)
Correlation between joint hypermobility (Beighton score) and Erythrocyte aggregation (Tr)
Erythrocyte aggregation (Tr), measured using Lorrca MaxSis under standardized conditions at 37°C and joint hypermobility (Beighton score)
Measured: At baseline (single time point)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start4 Apr 2024
- Primary completion20 Jan 2025
- Study completion7 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Adolescent ScoliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Saglik Bilimleri Universitesi
- Responsible party
- Principal investigator, Aslinur Keles Ercisli, MD, PhD, Fatih Sultan Mehmet Training and Research Hospital
- Investigators
- Papatya Keles, professor, Study director, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07102862
- Sponsor's protocol ID
- AHIAIS-2025
- Other IDs
- SBU-2025
- Acronym
- AHIAIS
- Status last verified
- Jul 2025
- First submitted
- 9 Jul 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to privacy concerns and institutional policies. The data contains sensitive health information that cannot be sufficiently de-identified for public distribution.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unveiling Altered Hemorheology in Adolescent Idiopathic Scoliosis: a Cross-sectional Case-control Study
- ClinicalTrials.gov ID
- NCT07102862
- Acronym / sponsor ID
- AHIAIS / AHIAIS-2025
- Conditions
- Idiopathic Adolescent Scoliosis
- Keywords
- Idiopathic Adolescent Scoliosis, hemorheology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Collaborators
- Saglik Bilimleri Universitesi
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 7 Jun 2025 (actual)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –10-18 years old AIS patients |
| Control Healthy Subjects | – | –Sex and aged match healthy subjecyts |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- This case-control study occurred at the University of Health Sciences in Istanbul from January to May 2025. Participation was voluntary, and written informed consent was obtained from both the adolescents and their legal guardians prior to data collection. Adolescents with idiopathic scoliosis will initially be recruited. An equal number of age-matched and sex-matched healthy controls will also be included. All participants will undergo the same evaluation protocol, and inclusion/exclusion criteria will be applied consistently across both groups.
Key inclusion criteria (2 listed)
- Presence of structural scoliosis with a Cobb angle greater than 10°
- Age between 10 and 18 years
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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).
Erythrocyte deformability (EImax)
Time frame: At baseline (single time point)
Evaluation of erythrocyte elongation index (EImax) using laser-assisted ektacytometry (Lorrca MaxSis).
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).
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.
Erythrocyte aggregation (Tr)
Time frame: At baseline (single time point)
Measurement of relaxation time (Tr) using Lorrca MaxSis at 37°C under standardized conditions.
42 secondary outcomes
Correlation between Cobb angle and the Plasma viscosity (mPa·s)
Time frame: At baseline (single time point)
Correlation between cervical lordosis angle and the Plasma viscosity (mPa·s)
Time frame: At baseline (single time point)
Correlation between thoracic kyphosis angle and the Plasma viscosity (mPa·s)
Time frame: At baseline (single time point)
Correlation between lumbar lordosis angle and the Plasma viscosity (mPa·s)
Time frame: At baseline (single time point)
Correlation between angle of trunk rotation (ATR) and the Plasma viscosity (mPa·s)
Time frame: At baseline (single time point)
Correlation between vertebral rotation (Nash-Moe grade) and the Plasma viscosity (mPa·s)
Time frame: At baseline (single time point)
Correlation between joint hypermobility (Beighton score) and the Plasma viscosity (mPa·s)
Time frame: At baseline (single time point)
Correlation between Cobb angle and the Whole blood viscosity (mPa·s)
Time frame: At baseline (single time point)
Correlation between cervical lordosis angle and the Whole blood viscosity (mPa·s)
Time frame: At baseline (single time point)
Correlation between thoracic kyphosis angle and the Whole blood viscosity (mPa·s)
Time frame: At baseline (single time point)
Correlation between lumbar lordosis angle and the Whole blood viscosity (mPa·s)
Time frame: At baseline (single time point)
Correlation between angle of trunk rotation (ATR) and the Whole blood viscosity (mPa·s)
Time frame: At baseline (single time point)
Correlation between vertebral rotation (Nash-Moe grade) and the Whole blood viscosity (mPa·s)
Time frame: At baseline (single time point)
Correlation between joint hypermobility (Beighton score) and the Whole blood viscosity (mPa·s)
Time frame: At baseline (single time point)
Correlation between Cobb angle and Erythrocyte deformability (EImax)
Time frame: At baseline (single time point)
Correlation between cervical lordosis angle and Erythrocyte deformability (EImax)
Time frame: At baseline (single time point)
Correlation between thoracic kyphosis angle and Erythrocyte deformability (EImax)
Time frame: At baseline (single time point)
Correlation between lumbar lordosis angle and Erythrocyte deformability (EImax)
Time frame: At baseline (single time point)
Correlation between angle of trunk rotation (ATR) and Erythrocyte deformability (EImax)
Time frame: At baseline (single time point)
Correlation between vertebral rotation (Nash-Moe grade) and Erythrocyte deformability (EImax)
Time frame: At baseline (single time point)
Correlation between joint hypermobility (Beighton score) and Erythrocyte deformability (EImax)
Time frame: At baseline (single time point)
Correlation between Cobb angle and Erythrocyte deformability (SS1/2)
Time frame: At baseline (single time point)
Correlation between cervical lordosis angle and Erythrocyte deformability (SS1/2)
Time frame: At baseline (single time point)
Correlation between thoracic kyphosis angle and Erythrocyte deformability (SS1/2)
Time frame: At baseline (single time point)
Correlation between lumbar lordosis angle and Erythrocyte deformability (SS1/2)
Time frame: At baseline (single time point)
Correlation between angle of trunk rotation (ATR) and Erythrocyte deformability (SS1/2)
Time frame: At baseline (single time point)
Correlation between vertebral rotation (Nash-Moe grade) and Erythrocyte deformability (SS1/2)
Time frame: At baseline (single time point)
Correlation between joint hypermobility (Beighton score) and Erythrocyte deformability (SS1/2)
Time frame: At baseline (single time point)
Correlation between Cobb angle and Erythrocyte aggregation (AI)
Time frame: At baseline (single time point)
Correlation between cervical lordosis angle and Erythrocyte aggregation (AI)
Time frame: At baseline (single time point)
Correlation between thoracic kyphosis angle and Erythrocyte aggregation (AI)
Time frame: At baseline (single time point)
Correlation between lumbar lordosis angle and Erythrocyte aggregation (AI)
Time frame: At baseline (single time point)
Correlation between angle of trunk rotation (ATR) and Erythrocyte aggregation (AI)
Time frame: At baseline (single time point)
Correlation between vertebral rotation (Nash-Moe grade) and Erythrocyte aggregation (AI)
Time frame: At baseline (single time point)
Correlation between joint hypermobility (Beighton score) and Erythrocyte aggregation (AI)
Time frame: At baseline (single time point)
Correlation between Cobb angle and Erythrocyte aggregation (Tr)
Time frame: At baseline (single time point)
Correlation between cervical lordosis angle and Erythrocyte aggregation (Tr)
Time frame: At baseline (single time point)
Correlation between thoracic kyphosis angle and Erythrocyte aggregation (Tr)
Time frame: At baseline (single time point)
Correlation between lumbar lordosis angle and Erythrocyte aggregation (Tr)
Time frame: At baseline (single time point)
Correlation between angle of trunk rotation (ATR) and Erythrocyte aggregation (Tr)
Time frame: At baseline (single time point)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Lazari D, Freitas Leal JK, Brock R, Bosman G. The Relationship Between Aggregation and Deformability of Red Blood Cells in Health and Disease. Front Physiol 2020;11:288.Link provided by the sponsor.
- Ebenuwa I, Violet P-C, Tu H, Lee C, Munyan N, Wang Y, et al. Altered RBC deformability in diabetes: clinical characteristics and RBC pathophysiology. Cardiovasc Diabetol 2024;23:370.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to privacy concerns and institutional policies. The data contains sensitive health information that cannot be sufficiently de-identified for public distribution.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Papatya Keles, professor study director
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Adolescent Scoliosis, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma viscosity (PV) (time frame: At baseline (single time point)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.