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

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Hyperkyphosis, Adolescent, Scheuermann Disease, Spinal Curvatures

Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 6 months after from beginning | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Scheuermann Disease, Adolescent Hyperkyphosis, Sagittal Balance, Spinopelvic Parameters