Skip to content

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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04924556
Enrollment
40
Registered
2021-06-14
Start date
2021-03-29
Completion date
2021-08-16
Last updated
2021-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperkyphosis, Adolescent, Scheuermann Disease, Spinal Curvatures

Keywords

Scheuermann Disease, Adolescent Hyperkyphosis, Sagittal Balance, Spinopelvic Parameters

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.

Interventions

None listed

Sponsors

Medipol University
CollaboratorOTHER
Başakşehir Çam & Sakura City Hospital
CollaboratorOTHER_GOV
Halic University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change from kyphosis angle at 6 months6 months after from beginning of studyChange from Baseline kyphosis angle(degree) in standing full-length lateral digital radiographs at 6 months. It will measure between T4-T12 vertebra.
Change from lordosis angle at 6 months6 months after from beginning of studyChange 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.
Change from the global tilt at 6 months6 months after from beginning of studyChange 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.
Change from Global Alignment and Proportion (GAP) score at 6 months6 months after from beginningGAP 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactAhsen Büyükaslan, PhD(c)
ahsen.buyukaslan@gmail.com905336992960

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026