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

NCT04924556 | Unknown

• 1 other identifier: HUEK-
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperkyphosis, Adolescent; Scheuermann Disease; Spinal Curvatures

Keywords

Scheuermann Disease; Adolescent Hyperkyphosis; Sagittal Balance; Spinopelvic Parameters

Outcome Measures

Primary Outcomes (4)

• 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

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

10-18 years patients with Scheuermann's kyphosis or adolescent hyperkyphosis and treated with CAD-CAM design a rigid brace

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Halic University: lead
• Medipol University: collaborator
• Başakşehir Çam & Sakura City Hospital: collaborator

Study Sites (1)

Formed Healthcare Scoliosis Treatment and Brace Center

Istanbul, İ̇stanbul, 34384, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Scheuermann Disease; Spinal Curvatures

Condition Hierarchy (Ancestors)

Spinal Osteochondrosis; Osteochondrosis; Bone Diseases; Musculoskeletal Diseases; Kyphosis; Spinal Diseases

Study Officials

• Ahsen Büyükaslan, PhD(c)

  Medipol University

  PRINCIPAL INVESTIGATOR

• Kadir Abul, M.D.

  Başakşehir Çam & Sakura City Hospital

  STUDY CHAIR

• Hürriyet Yılmaz, Prof.Dr.

  Halic University

  STUDY DIRECTOR

Central Study Contacts

Ahsen Büyükaslan, PhD(c)

CONTACT

905336992960; ahsen.buyukaslan@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: June 14, 2021
• Study Start: March 29, 2021
• Primary Completion: June 14, 2021
• Study Completion: August 16, 2021
• Last Updated: June 14, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)