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Completed

NCT Number: NCT06021314

Brace Efficiency and Generalized Joint Hypermobility

The goal of this observational study is to learn about effect of generalised joint hypermobility on the effectiveness of the brace in children with Adolesan Idiopatic Scoliosis and who use braces due to brace indication.

The main questions it aims to answer are:

* Does Generalized Joint Hypermobility have an effect on the amount of in-brace improvement achieved in children using braces? * Does Generalized Joint Hypermobility have an effect on the change in the numerical variables related to scoliosis recorded in the out-brace measurement at the end of 6 months?

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Key information

Conditions

Scoliosis Idiopathic Hypermobility, Joint Joint Diseases Joint Instability Musculoskeletal Diseases

Age range

10 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Senay Cerezci Duygu

Ankara, Keçiören, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being under brace treatment due to the diagnosis of adolescent idiopathic scoliosis.
  • Having a standing posterior-anterior radiograph before and during the brace use.
  • Having a curve of 20 degree and above according to the Cobb angle.
  • Confirmation of participation.

Exclusion criteria

  • Having systemic diseases related to GJH (Ehlers-Danlos, Down, Marfan, Larsen).

Treatment and study plan

Brace

Other

Cheneau type scoliosis brace due to brace indication for adolecant idiopatic scoliosis

Primary outcomes

  1. Change of in-brace scoliosis angle

    Time frame: Measurement-1: Just before starting the brace use (Retrospectively)/ Measurement-2: In-brace condition at the 4th week of the brace use

    "Cobb angle" will be taken as reference to determine the scoliosis angle. For Cobb angle measurement, the angle between the upper border of the upper vertebra and the lower border of the lowest vertebra will be calculated.

    In order to determine change of scoliosis angle with brace use, the x-ray image taken just before starting to use the brace and the x-ray image taken while the brace is on the participant (in-brace condition) at the 4th week of brace usage will be evaluated. The difference between the two measurements will be recorded as change of in-brace scoliosis angle.

  2. Generalised Joint Hypermobility

    Time frame: After participant being included in the study, latest at the 4th week of the brace use.

    A nine-degree "Beighton scale" will be used to determine the occurrence of generalized joint hypermobility. Additionally, a five-part questionnaire by Hakim and Graham will be used. Obtaining 4 or more points on Beighton scale and simultaneously at least 2 points in the ques-tionnaire by Hakim and Graham will be adopted as a criterion for generalized joint hypermobility diagnosis.

Secondary outcomes

  1. Change of in-brace vertebral rotation

    Time frame: Measurement-1: Just before starting the brace use (Retrospectively)/ Measurement-2: In-brace condition at the 4th week of the brace use

    The evaluation of vertebral rotation on radiographs will be made using the Raimondi method regolo (Marrapese Editore-Demi S.r.1., Rome). In roimondi method; through the offset shadow, the widths of the vertebral body are measured in millimeters. The width of each vertebra is determined on the anterior-posterior X-ray at the most narrow spot, the so called vertebral waist. The convex-sided pedicle is marked and bisected longitudinally by a line. In order to determine the pedicle offset, the distance of this bisecting line to the convexsided waist of the vertebral body is evaluated. The value of vertebral rotation is obtained by inserting the width and the pedicle offset in the Raimondi method regolo. The difference between the two measurements will be recorded as in-brace improvement at scoliosis angle.

  2. Change of in-brace spinal height

    Time frame: Measurement-1: Just before starting the brace use (Retrospectively)/ Measurement-2: In-brace condition at the 4th week of the brace use

    The distance between T1-S1 vertebral bodies in the x-ray image will be recorded in mm to determine the spinal height. The difference between the two measurements will be recorded as change of in-brace spinal height.

  3. Change of in-brace global cronal balance

    Time frame: Measurement-1: Just before starting the brace use (Retrospectively)/ Measurement-2: In-brace condition at the 4th week of the brace use

    The distance between T the midpoint of the C7 vertebra and the central sacral vertical line (CSVL) in the x-ray image will be recorded in mm to determine the global cronal balance of spine. The difference between the two measurements will be recorded as change of in-brace global cronal balance.

  4. Change of in-brace apical translation

    Time frame: Measurement-1: Just before starting the brace use (Retrospectively)/ Measurement-2: In-brace condition at the 4th week of the brace use

    The distance between the center of apical vertebra in the major curve and the sacral vertical line (CSVL) in the x-ray image will be recorded in mm to determine the global cronal balance of spine. The difference between the two measurements will be recorded as change of in-brace apical translation.

  5. Brace compliance

    Time frame: in-brace condition at the 4th week of the brace use

    Daily usage hours and total brace usage time will be questioned retrospectively at the 4th week of brace use.

Sponsors and collaborators

Lead sponsor

Baskent University

Other

Collaborators

  • Gulhane School of Medicine

Registry information

Official study title

Investigation of the Relationship Between Generalized Joint Hypermobility and Brace Efficiency in Adolescent Idiopathic Scoliosis

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 1, 2023
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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