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

Nippon Sigmax co., ltd.

Status: Active, not recruiting

Conditions: Adolescent Idiopathic Scoliosis (AIS)

Treatments: Device: Spinal bracing

Study type: Observational

Funder types: Industry

Identifiers

NCT07040150

AMEC brace study

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 10 to 15 years old

Volunteers: No Healthy Volunteers

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