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Adolescent Idiopathic ScoliosisNCT04382638

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

A study testing RCO group and TLSO group in people with Adolescent Idiopathic Scoliosis, run by The University of Hong Kong at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 10 to 15 years
Conditions the study is for
Adolescent Idiopathic Scoliosis
What is being tested?
RCO group and TLSO group
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
134 participants
Where
1 siteHong Kong
Study dates
2 Jul 2022to 3 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Dr Kenny Kwan, BMBCh (Oxon) contact

+852 22554654

kyhkwan@hku.hk

Ms Lee Yin Goh, MSc contact

+852 22554654

lygoh@hku.hk

Hong Kong1 site, 1 recruiting
  • Duchess of Kent Children's Hospital

    Hong Kong

    Dr Kenny Kwan, BMBCh (Oxon), +852 22554654, kyhkwan@hku.hk

    Ms Lee Yin Goh, MSc, +852 22554654, lygoh@hku.hk

    Recruiting

Other trials in Hong Kong

About this study

Official title: Effectiveness of Three Dimensional Correction During in Bracing in Adolescent Idiopathic Scoliosis: a Prospective Randomised Clinical Trial of Rigo Chêneau Versus Boston-style Orthoses

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.

Read the detailed description

Adolescent idiopathic scoliosis (AIS), a three-dimensional (3D) deformity of the spinal column characterized by lateral deviation and vertebral rotation, affects 3.5% of children during puberty in Hong Kong. Untreated scoliosis continues to deteriorate beyond adolescence, and curves that progress beyond 50 degrees can lead to chronic back pain, cardiopulmonary compromise, poor cosmesis and negative psychological impact. Hence, surgical correction of the deformity by instrumented spinal fusion is recommended when curves reach 50 degrees. Although surgical risks have decreased with improved techniques, surgeries for scoliosis correction still carry significant medical co-morbidities, psychological stress to the children and their families, and substantial financial burden on healthcare. Effective non-operative strategies to prevent curve progression during adolescence are needed. Currently, the most effective non-operative treatment supported by high quality randomised controlled trial to prevent curve progression is by spinal bracing. In the Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST) study, bracing was effective in preventing curve progression to threshold for surgery in 72% of cases. The failure rate, therefore, remains substantially high despite the best available non-operative treatment. Previous studies have identified factors affecting brace success, including skeletal age, curve type, curve magnitude, and flexibility, but none of these is modifiable. Brace treatment requires a wholistic approach, and brace design and fabrication are important determinants of brace effectiveness. Traditional Boston-style thoracolumbosacral orthoses (TLSO), such as those used in the BrAIST study, can achieve in-brace coronal curve correction reliably but their effects on the 3D curve correction are highly variable. Since AIS is a 3D deformity, it is reasonable to postulate that braces which can achieve correction in all three planes have a higher chance of success.

Rigo Chêneau orthoses (RCO) were developed approximately two decades ago by Dr. Manuel Rigo of Barcelona who made improvements to the Chêneau brace that French doctor Jacques Chêneau invented in 1978. RCO was designed with the intent to combine biomechanical forces in three dimensions, including curve derotation. They use an open pelvis design with anterior opening. Instead of focusing on one-dimensional correction, RCO treats scoliosis in all three dimensions and follows a unique curve Rigo classification protocol to guide brace design. RCO not only keeps the curves from getting worse as seen on an X-ray, but also corrects as much as possible the way the body looks. Every attempt is made to decrease the noticeable effects of scoliosis such as rib humps, uneven shoulders, hips which are translated or rotated, and centering the head over the pelvis. To achieve successful 3D scoliosis correction, in-brace Cobb angle correction must be 50% to be considered acceptable. This is often true and it is also true that the Cobb angle, which is easily assessed, has been the gold standard of measurement for brace quality. However, not all patients can and/or should be corrected to 50% in-brace correction. In some cases, a 25% in-brace correction coupled with good 3D correction is acceptable and sufficient to prevent scoliosis progression, when greater Cobb angle correction would cause negative compensations. Overall, some patients are best served by targeting a low in-brace correction, whereas for others an 80% in-brace correction is both achievable and desirable.

Being tested
RCO group, TLSO group
Keywords
AIS

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

Study groups in NCT04382638
Study groupRoleWhat they receive
RCO groupExperimentalPatients 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.
Receives: Combination Product: RCO group
TLSO groupActive comparatorPatients 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.
Receives: Device: TLSO group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (9)
  1. Compare changes in sagittal plane radiological parameter between RCO versus TLSO by EOS Imaging System

    To evaluate the effect of in-brace 3D scoliosis correction between RCO versus TLSO on sagittal plane radiological parameter using EOS Imaging System

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

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

    To evaluate the effect of in-brace 3D scoliosis correction between RCO versus TLSO on transverse plane radiological parameter using EOS Imaging System

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

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

    To evaluate the effect of RCO during in-bracing on surface topography using Bunnell's scoliometer with a range from 0 degree to 30 degree (left/right). Reading closer to 0 degree indicates better surface topography

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

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

    To evaluate the effect of RCO during in-bracing on surface topography using clinical photography

    Measured: baseline, 6 months, 12 months up to 5 years

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

    To evaluate the effect of RCO during in-bracing on surface topography using VITUS Smart XXL 3D body scanner system

    Measured: baseline, 6 months, 12 months up to 5 years

  6. Measure changes in quality of life between RCO versus TLSO by Scoliosis Research Society-7 questionnaire

    To measure changes in quality of life between RCO versus TLSO by Scoliosis Research Society-7 questionnaire, with the minimum score of 22 to the maximum score of 110. Higher score indicates better health outcome

    Measured: baseline, 6 months, 12 months up to 5 years

  7. Measure changes in health outcome between RCO versus TLSO by EQ-5D-5L

    To measure changes in health outcome between RCO versus TLSO by EQ-5D-5L, with the part of EQ-VAS score ranging from the minimum of 0 to the maximum of 100. Higher score indicates better health outcome

    Measured: baseline, 6 months, 12 months up to 5 years

  8. Measure changes in patients' perception of their appearance between RCO versus TLSO by Trunk Appearance Perception Scale

    To measure changes in patients' perception of their appearance between RCO versus TLSO by Trunk Appearance Perception Scale with 5 graphical illustrations. Graph 1 represents the patient's best self-perception of his or her appearance while graph 5 represents the patient's worst self-perception of his or her appearance

    Measured: baseline, 6 months, 12 months up to 5 years

  9. Measure changes in levels of pain between RCO versus TLSO by Numeric Pain Ratings

    To measure changes in levels of pain between RCO versus TLSO by Numeric Pain Ratings with a range from the minimum of 0 to the maximum of 10. Lower score indicates less pain.

    Measured: baseline, 6 months, 12 months up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2020
  2. Study start2 Jul 2022
  3. Primary completion3 Jul 2025 (estimated)
  4. Study completion3 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
134 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04382638
Sponsor's protocol ID
UW 20-243
Status last verified
Feb 2023
First submitted
5 May 2020
Last updated
6 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing RCO group and TLSO group in people with Adolescent Idiopathic Scoliosis, run by The University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Dr Kenny Kwan, BMBCh (Oxon) (+852 22554654, kyhkwan@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: baseline, 3 months, 6 months, 12 months up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.

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