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

NCT ID: NCT04924556

Last Updated: 2021-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-29

Study Completion Date

2021-08-16

Brief Summary

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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

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Conditions

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Hyperkyphosis, Adolescent Scheuermann Disease Spinal Curvatures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medipol University

OTHER

Sponsor Role collaborator

Başakşehir Çam & Sakura City Hospital

OTHER_GOV

Sponsor Role collaborator

Halic University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ahsen Büyükaslan, PhD(c)

Role: PRINCIPAL_INVESTIGATOR

Medipol University

Kadir Abul, M.D.

Role: STUDY_CHAIR

Başakşehir Çam & Sakura City Hospital

Hürriyet Yılmaz, Prof.Dr.

Role: STUDY_DIRECTOR

Halic University

Locations

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Formed Healthcare Scoliosis Treatment and Brace Center

Istanbul, İ̇stanbul, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Ahsen Büyükaslan, PhD(c)

Role: CONTACT

905336992960

Facility Contacts

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Ahsen Büyükaslan, MSc.

Role: primary

05336992960

Other Identifiers

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HUEK-

Identifier Type: -

Identifier Source: org_study_id

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