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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Ahsen Büyükaslan, PhD(c); Phone Number: 905336992960; Email: ahsen.buyukaslan@gmail.com

Study Locations

• Turkey
  • İ̇stanbul
    • Istanbul, İ̇stanbul, Turkey, 34384
      • Recruiting
      • Formed Healthcare Scoliosis Treatment and Brace Center
      • Contact: Ahsen Büyükaslan, MSc.; Phone Number: 05336992960; Email: ahsen.buyukaslan@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 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

Collaborators and Investigators

• Sponsor: Halic University
• Collaborators: Medipol University; Basaksehir Cam & Sakura Şehir Hospital
• Investigators: Study Director: Hürriyet Yılmaz, Prof.Dr., Haliç University; Principal Investigator: Ahsen Büyükaslan, PhD(c), Medipol University; Study Chair: Kadir Abul, M.D., Basaksehir Cam & Sakura Şehir Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2021
• Primary Completion (Anticipated): June 14, 2021
• Study Completion (Anticipated): August 16, 2021

Study Registration Dates

• First Submitted: May 26, 2021
• First Submitted That Met QC Criteria: June 9, 2021
• First Posted (Actual): June 14, 2021

Study Record Updates

• Last Update Posted (Actual): June 14, 2021
• Last Update Submitted That Met QC Criteria: June 9, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Scheuermann Disease; Adolescent Hyperkyphosis; Sagittal Balance; Spinopelvic Parameters
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Osteochondrosis; Spinal Curvatures; Kyphosis; Scheuermann Disease; Spinal Osteochondrosis
• Other Study ID Numbers: HUEK-

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No