Immediate in-brace correction: Optimized Brace for Scoliosis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
CHU Sainte-Justine, Montreal, Canada
Scoliosis+1 More
Immediate in-brace correction: Optimized Brace - Device
Eligibility
< 18
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether a new brace design can improve the effectiveness of brace treatment for scoliosis.

See full description

Eligible Conditions

  • Scoliosis
  • Scoliosis Idiopathic

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Immediate in-brace correction: Optimized Brace will improve 1 primary outcome and 4 secondary outcomes in patients with Scoliosis. Measurement will happen over the course of 5 minutes after brace fitting.

1 year, 2 years
Quality of Life (QoL) - MOBI
5 minutes after brace fitting
Immediate in-brace Cobb angle
Year 2
Change in Cobb angle
Quality of Life (QoL) - SRS-22r
Treatment failure rate

Trial Safety

Trial Design

2 Treatment Groups

Conventional Providence brace
1 of 2
Optimized Providence brace
1 of 2
Active Control
Experimental Treatment

This trial requires 58 total participants across 2 different treatment groups

This trial involves 2 different treatments. Immediate In-brace Correction: Optimized Brace is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Optimized Providence braceThe braces will be designed using optimization and finite element analysis.
Conventional Providence braceThe braces will be designed by an orthotist using the conventional design method.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year, 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 year, 2 years for reporting.

Who is running the study

Principal Investigator
H. L.
Hubert Labelle, MD
St. Justine's Hospital

Closest Location

CHU Sainte-Justine - Montreal, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Primary curve angles 20 degrees - 40 degrees
AIS diagnosis
If female, either premenarchal or less than 18 months postmenarchal.
Risser 0-2

Patient Q&A Section

What are common treatments for scoliosis?

"Treatment of scoliosis depends on the type of curve it presents, the age of the patient, and whether or not there is neurological compromise. Common treatments of scoliosis include bracing, physiotherapy, and nonsurgical options like exercises, massage, and electrical stimulation.\n" - Anonymous Online Contributor

Unverified Answer

How many people get scoliosis a year in the United States?

"About 2.4 million people will be diagnosed with idiopathic scoliosis and about 2.9 million people will have scoliosis related to a known skeletal disorder. The American Academy of Orthopaedic Surgery estimates there will be 27,500 new cases of scoliosis in 2018. scoliosis -patient.gov\n" - Anonymous Online Contributor

Unverified Answer

What are the signs of scoliosis?

"The signs and symptoms of scoliosis are similar to other spinal curvature anomalies such as kyphosis or lordosis. Each is most obvious on a curve of the upper thoracic region. Scoliosis may cause a variety of symptoms, many of which are non-specific and may mimic other medical conditions such as neck pain, fever, or a head injury. Patients with scoliosis are more likely to suffer other medical conditions that arise when a curved spinal region is used during posture, posture in the kneeling position, or postures involving rotation beyond 90°." - Anonymous Online Contributor

Unverified Answer

Can scoliosis be cured?

"Overall, these children underwent successful management of their scoliosis. Treatment of scoliosis is often a collaborative effort between surgeon, rehabilitation physician and (or) physiatrist. In the short term, careful follow-up and monitoring of these children is important to ensure that the natural history of the disease is followed." - Anonymous Online Contributor

Unverified Answer

What is scoliosis?

"The term scoliosis is used to denote a complex, multi-disciplinary clinical entity. The name has undergone significant evolution from early observations that the scoliosis was a curve to its current usage in a descriptive manner. It should be emphasised that scoliosis is not solely a clinical entity, rather it is associated with many disorders and should always be considered along the context." - Anonymous Online Contributor

Unverified Answer

What causes scoliosis?

"Scoliosis is a multifaceted disorder with an extraordinarily diverse set of abnormalities and etiologies. Early detection and prompt diagnosis are essential to provide appropriate treatment, to minimize disability and to reduce deformity progression. The following cases were chosen to represent some of the various causes of scoliosis." - Anonymous Online Contributor

Unverified Answer

What is the latest research for scoliosis?

"The treatment approaches that are currently employed in the management of children with idiopathic scoliosis are varied and evolving as newer scientific information regarding the epidemiology and pathophysiology of scoliosis are made available. Further, evidence-based guidelines and recommendations are evolving regarding the specific role for orthopaedic surgeons in the scoliosis surgical program." - Anonymous Online Contributor

Unverified Answer

How does immediate in-brace correction: optimized brace work?

"Although optimized brace works without any extra effort in the first month of its application, it deteriorates with time, particularly by rotation. This effect is more pronounced in patients younger than 15 years, who often exhibit progressive scoliosis. Therefore, early application of the device seems beneficial, and the benefit seems to be maintained after the initial 1 month." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving immediate in-brace correction: optimized brace?

"This was the first clinical trial to demonstrate a patient specific brace design that was an appropriate immediate correction brace using patient anthropometric findings to optimize post-operative results. Results from a recent clinical trial demonstrated that the results of the brace design is comparable to surgical results when used prior to the surgery. The advantages of using immediate post-operative correction brace is to improve patient compliance with the brace. It also allows further evaluation of brace design and surgical techniques to improve results in the long term." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for scoliosis?

"Subjects who have a scoliosis of 10° or less with no known or suspected neurological dysfunction are most likely to qualify for trial enrollment, while older children aged 5 years or older are not candidates for enrollment in large trials if they show progressive scoliosis or exhibit neurological dysfunction. The trial database may be an effective means of sharing information and conducting research." - Anonymous Online Contributor

Unverified Answer

What does immediate in-brace correction: optimized brace usually treat?

"The authors believe it can improve compliance of patient as they will understand more about brace treatment and have the support of healthcare team to take good preventive measures. The authors were not allowed to choose their own brace treatment. If authors want to make some other data combination with the existing research and data it would be great" - Anonymous Online Contributor

Unverified Answer

What is the primary cause of scoliosis?

"The following are the various pathologies implicated in its development as reported in the literature. They include a congenital one, but also neuromuscular causes, like cerebral palsy, or chronic low [back pain](https://www.withpower.com/clinical-trials/back-pain): ankylosing spondylitis, which is a combination of several diseases that result in a painful deformity of the spinal column in a similar way as scoliosis." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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