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

• Conditions: Spinal Curvatures; Hyperkyphosis, Adolescent; Scheuermann Disease

• Registration Number: NCT04924556
• Lead Sponsor: Halic University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-29
• Study First Submitted: 2021-05-26
• Status Verified: 2021-06
• Study First Submitted QC: 2021-06-09
• Last Update Submitted: 2021-06-09
• Primary Completion: 2021-06-14
• Study First Posted: 2021-06-14
• Last Update Posted: 2021-06-14
• Study Completion: 2021-08-16

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from Global Alignment and Proportion (GAP) score at 6 months	6 months after from beginning	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.
Change from kyphosis angle at 6 months	6 months after from beginning of study	Change 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 months	6 months after from beginning of study	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.
Change from the global tilt at 6 months	6 months after from beginning of study	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.

Trial Locations

Locations (1)

Formed Healthcare Scoliosis Treatment and Brace Center; 🇹🇷 Istanbul, İ̇stanbul, Turkey