NCT04382638

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 11, 2020

Completed
2.1 years until next milestone

Study Start

First participant enrolled

July 2, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2025

Completed
Last Updated

February 6, 2023

Status Verified

February 1, 2023

Enrollment Period

3 years

First QC Date

May 5, 2020

Last Update Submit

February 2, 2023

Conditions

Adolescent Idiopathic Scoliosis

Keywords

AIS

Outcome Measures

Primary Outcomes (1)

  • Effect of in-brace 3D scoliosis correction between RCO versus TLSO as determined by the difference in coronal Cobb angle pre- and one year post-treatment

    To evaluate the effect of in-brace 3D scoliosis correction between RCO versus TLSO as determined by the difference in coronal Cobb angle pre- and one year post-treatment

    baseline, 3 months, 6 months, 12 months up to 5 years

Secondary Outcomes (9)

  • Compare changes in sagittal plane radiological parameter between RCO versus TLSO by EOS Imaging System

    baseline, 3 months, 6 months, 12 months up to 5 years

  • Compare changes in transverse plane radiological parameter between RCO versus TLSO by EOS Imaging System

    baseline, 3 months, 6 months, 12 months up to 5 years

  • Compare changes in surface topography between RCO versus TLSO using Bunnell's scoliometer

    baseline, 3 months, 6 months, 12 months up to 5 years

  • Compare changes in surface topography between RCO versus TLSO using clinical photography

    baseline, 6 months, 12 months up to 5 years

  • Compare changes in surface topography between RCO versus TLSO using VITUS Smart XXL 3D body scanner system

    baseline, 6 months, 12 months up to 5 years

  • +4 more secondary outcomes

Study Arms (2)

RCO group

EXPERIMENTAL

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.

Combination Product: RCO group

TLSO group

ACTIVE COMPARATOR

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.

Device: TLSO group

Interventions

RCO groupCOMBINATION_PRODUCT

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.

RCO group
TLSO groupDEVICE

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.

TLSO group

Eligibility Criteria

Age10 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosis of AIS
  • Male or female from 10 to 15 year-old, inclusive, at the time of consent provided
  • Skeletal immaturity, defined as a Risser grade (amount of ossification and eventual fusion of the iliac apophysis) of 0, 1, or 2
  • Cobb angle of 25-40
  • No prior conservative or surgical treatment for AIS

You may not qualify if:

  • An underlying cause or association that may cause scoliosis
  • Leg length discrepancies or lower limb deformities that may interfere with spinal posture
  • Previous spinal surgery
  • Cognitive impairment
  • Those receiving any other forms of treatment including alternative medicine for the treatment of their scoliosis
  • Those who are unable to return for follow-up to complete the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duchess of Kent Children's Hospital

Hong Kong, Hong Kong

RECRUITING

Study Officials

  • Dr Kenny Kwan, BMBCh (Oxon)

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Kenny Kwan, BMBCh (Oxon)

CONTACT

+852 22554654kyhkwan@hku.hk

Ms Lee Yin Goh, MSc

CONTACT

+852 22554654lygoh@hku.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Assessor, statistician and investigator blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients diagnosed with AIS referred for bracing through the hospital's specialist outpatient clinic are eligible to enrol the study. The Investigator will document whether each patient meets the selection criteria before enrolment into the study. The Investigator or designee will also obtain an IRB/EC approved Informed consent from each patient and/or guardian. Eligible patients will be randomly assigned to either RCO group (experimental) or TLSO group (control) in a ratio of 1:1. The radiographic evaluation, physical examination and PROM questionnaires will be assessed at baseline, 3 months, 6 months, 12 months and every year until patients reach skeletal maturity or if surgical intervention is required.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

May 5, 2020

First Posted

May 11, 2020

Study Start

July 2, 2022

Primary Completion

July 3, 2025

Study Completion

December 3, 2025

Last Updated

February 6, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)