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

Spinal Curvatures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04924556
• Other study ID #: HUEK-
• Status: Recruiting
• Start date: March 29, 2021
• Est. completion date: August 16, 2021

Study information

• Verified date: June 2021
• Source: Halic University
• Contact: Ahsen Büyükaslan, PhD(c)
• Phone: 905336992960
• Email: ahsen.buyukaslan[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 16, 2021
• Est. primary completion date: June 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

Inclusion Criteria:

• Subjects who diagnosed with Scheuermann's kyphosis or adolescent hyperkyphosis.
• Initial 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.

Related Conditions & MeSH terms

• Kyphosis
• Scheuermann Disease
• Spinal Curvatures
• Spinal Osteochondrosis

Locations

Country	Name	City	State
Turkey	Formed Healthcare Scoliosis Treatment and Brace Center	Istanbul	I?stanbul

Sponsors (3)

Lead Sponsor	Collaborator
Halic University	Basaksehir Cam & Sakura Sehir Hospital, Medipol University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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