The Effect of Rıgıd Brace on Spinopelvic Parameters and GAP Score in Adolescents With Structural Hyperkyphosis

Halic University40 enrolled

Overview

This study aimed to investigate the effect of rıgıd brace treatment on spinopelvic parameters and GAP score in patients with adolescent hyperkyphosis. This was a retrospective analysis of prospectively collected data. Thirty-two patients who were diagnosed with structural hyperkyphosis and treated with CAD-CAM design rigid brace were included in the study in Formed Healthcare Scoliosis Treatment and Brace Center between December 2015-2020.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hyperkyphosis, Adolescent Scheuermann Disease Spinal Curvatures

Eligibility

Sex: ALLMin age: 10 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects who diagnosed with Scheuermann's kyphosis or adolescent hyperkyphosis. * Inıtial curve magnitude between 55-75° * Patients who followed up at least 6 months * Patients who wearing CAD-CAM (Computer-Aided Design\&Computer-Aided Manufacturing) design TLSO(Thoraco-lumbo-sacral orthosis) kyphosis brace in 16 hours/day or more Exclusion Criteria: * History of spinal surgery or trauma * Patients has kyphosis due to congenital, neuromuscular, traumatic, tumor, infection causes * Ankylosing spondylitis and other spondyloarthropathies. * The lack of appropriate full-length lateral radiography with acceptable quality at the baseline or final assessment.

Locations (1)

Formed Healthcare Scoliosis Treatment and Brace Center

Istanbul, İ̇stanbul, Turkey (Türkiye)

RECRUITING

Outcomes

Primary Outcomes

Change from kyphosis angle at 6 months

Change from Baseline kyphosis angle(degree) in standing full-length lateral digital radiographs at 6 months. It will measure between T4-T12 vertebra.

Time frame: 6 months after from beginning of study

Change from lordosis angle at 6 months

Change from Baseline lordosis angle(degree) in standing full-length lateral digital radiographs at 6 months. It will measure from the L1-S1 and L4-S1 levels of the vertebra.

Time frame: 6 months after from beginning of study

Change from the global tilt at 6 months

Change from Baseline global tilt(degree) in standing full-length lateral digital radiographs at 6 months. The global tilt is the sum of the C7 vertical tilt and the pelvic tilt.

Time frame: 6 months after from beginning of study

Change from Global Alignment and Proportion (GAP) score at 6 months

GAP score is a new pelvic incidence-based proportional method to analyze sagittal alignment and balance, developed by the European Spine Study Group (ESSG). The GAP score evaluates the disproportion, magnitude and distribution of lumbar lordosis, and the global spinopelvic alignment proportionally rather than an absolute numerical value when compared to the ideal calculated for any individual. GAP score has five domains including relative pelvic version, relative lumbar lordosis, lordosis distribution index, relative spinopelvic alignment, and age factor. Scores of each of the four domains vary between 0 to 3 and age factor domain varies between 0 to 1. The total GAP score is between 0 and 13 points and obtained by adding the scores of these five domains. If the total score was 0 to 2, alignment accepted as proportional; 3 to 6 as moderate malalignment; ≥7 was accepted as severe malalignment.

Time frame: 6 months after from beginning

Central Contacts

Ahsen Büyükaslan, PhD(c)

CONTACT

905336992960 ahsen.buyukaslan@gmail.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.