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NCT Number: NCT07040150

Evaluation of a Novel Semi-Rigid Brace for Adolescent Idiopathic Scoliosis

Introduction: Spinal bracing remains the gold standard for conservative management of adolescent idiopathic scoliosis (AIS). However, poor adherence often limits treatment efficacy. The development of a brace that enhances compliance while maintaining sufficient corrective force is crucial. This study aimed to develop and evaluate the effectiveness of a novel semi-rigid brace for AIS based on wearing time and correction rate.

Materials and Methods: The investigators enrolled patients who met the following Scoliosis Research Society (SRS) criteria for brace treatment: (1) confirmed AIS diagnosis, (2) Risser sign ≤ 2, (3) Cobb angle between 25° and 40°, (4) age ≥ 10 years, and (5) single-curve pattern. Wearing time was objectively measured over 180 days using embedded temperature sensors. Correction rates were assessed at initiation and after 180 days or more.

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Key information

Conditions

Adolescent Idiopathic Scoliosis (AIS)

Age range

10 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aizu Medical Center at Fukushima Medical University

Aizu-Wakamatsu, Fukushima, 969-3492, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • diagnosed AIS
  • Risser sign ≤ 2
  • Cobb angle between 25° and 40°
  • age ≥ 10 years
  • single-curve pattern (thoracic or thoracolumbar/ lumbar)
  • premenarchial or less than one year post-menarche.

Exclusion criteria

  • Patients who do not meet the SRS criteria for orthosis suitability
  • Patients with a history of spinal surgery

Treatment and study plan

Spinal bracing

Device

The semi-rigid spinal brace was developed to enhance patient compliance while maintaining effective curve correction. Patients were instructed to wear the brace for 18-20 h daily.

Primary outcomes

  1. Wearing time

    Time frame: 180 days from registration

Secondary outcomes

  1. Initial correction rate

    Time frame: Immediately after registration

  2. Correction rate after 180 days or more

    Time frame: 180 days or more from registration

  3. Treatment success rate

    Time frame: 2 years or more from registration

Sponsors and collaborators

Lead sponsor

Nippon Sigmax co., ltd.

Industry

Registry information

Official study title

Development and Short-Term Evaluation of a Novel Semi-Rigid Brace for Adolescent Idiopathic Scoliosis: Results From a Multicenter Prospective Observational Study of the First 60 Patients

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Jun 27, 2025
Registry last updated
Jul 1, 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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