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Effectiveness of Three Dimensional Correction During in Bracing in Adolescent Idiopathic Scoliosis

NCT04382638 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2023-02-06

No results posted yet for this study

Summary

The purpose of this study is to study the effectiveness of in-brace 3D scoliosis correction by comparing Rigo Chêneau orthoses (RCO) with conventional Traditional Boston-style thoracolumbosacral orthoses (TLSO) in Adolescent Idiopathic Scoliosis (AIS) patients, following Scoliosis Research Society (SRS) and The International Scientific Society on Scoliosis Orthopaedic and Rehabilitation Treatment (SOSORT) recommendations for non-operative AIS management and research studies. This group of patients that reach the threshold for bracing have an intrinsic higher risk for curve progression. Hence, the proposed study will provide novel and high quality evidence to improve the efficacy of bracing in the non-operative treatment of AIS. This will contribute significantly to the betterment of public health by reducing the number of patients requiring surgical intervention. Ultimately, new evidence-based clinical practice guidelines on the most effective type of scoliosis braces will benefit children diagnosed with AIS worldwide.

Conditions

  • Adolescent Idiopathic Scoliosis

Interventions

COMBINATION_PRODUCT

RCO group

Patients in the experimental group will receive RCO fabrication with standard level of care for bracing, which consists of education on general exercises for spinal movement, strengthening, and balancing. These patients will attend study assessments at baseline, 3 months, 6 months, 12 months and every year until they reach skeletal maturity or if surgical intervention is required.

DEVICE

TLSO group

Patients in the experimental group will receive TLSO fabrication with standard level of care for bracing, which consists of education on general exercises for spinal movement, strengthening, and balancing. These patients will attend study assessments at baseline, 3 months, 6 months, 12 months and every year until they reach skeletal maturity or if surgical intervention is required.

Sponsors & Collaborators

  • The Hong Kong Polytechnic University

    collaborator OTHER

  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • Dr Kenny Kwan, BMBCh (Oxon) · The University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-02
Primary Completion
2025-07-03
Completion
2025-12-03

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04382638 on ClinicalTrials.gov