Altered Hemorology in Adolescent Idıopathic Scoliosis

NCT ID: NCT07102862

Last Updated: 2025-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-04

Study Completion Date

2025-06-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Idiopathic Adolescent Scoliosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients

10-18 years old AIS patients

No interventions assigned to this group

Control Healthy Subjects

Sex and aged match healthy subjecyts

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Saglik Bilimleri Universitesi

OTHER

Sponsor Role collaborator

Fatih Sultan Mehmet Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Aslinur Keles Ercisli, MD, PhD

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Papatya Keles, professor

Role: STUDY_DIRECTOR

Saglik Bilimleri Universitesi

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Health Sciences

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Related Links

Access external resources that provide additional context or updates about the study.

https://pmc.ncbi.nlm.nih.gov/articles/PMC7174766/

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.

https://cardiab.biomedcentral.com/articles/10.1186/s12933-024-02453-2

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.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SBU-2025

Identifier Type: OTHER

Identifier Source: secondary_id

AHIAIS-2025

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Ultrasound-Assisted Brace Casting for AIS
NCT02996643 COMPLETED EARLY_PHASE1
Fixation of Medial Malleolar Fractures .
NCT07148375 ACTIVE_NOT_RECRUITING NA
Fixation of Fracture Neck of Femur in Children
NCT06267885 NOT_YET_RECRUITING NA