Optimized Nighttime Brace for Scoliosis

Overseen By Soraya Barchi

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: St. Justine's Hospital

Disqualifiers: Cardiovascular, Neurological, Musculoskeletal, Pregnancy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 years

58 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Adolescent Idiopathic Scoliosis affects 3-4% of the Canadian population, of which about 10% will need a brace treatment during pubertal growth spurt. Our team has developed an innovative conception method for brace design by optimizing for the immediate in-brace correction. The model is customized to each patient. In this project, the investigators will evaluate the effectiveness of this platform's customized treatment and validate its clinical application.

Are You a Good Fit for This Trial?

This trial is for young people with Adolescent Idiopathic Scoliosis (AIS) who have a primary curve of their spine between 20-40 degrees. Girls should be early in puberty, and all participants must not have advanced bone maturity (Risser 0-2). It's not open to those with cardiovascular or neurological disorders, other musculoskeletal issues affecting the legs, or if pregnant.

Inclusion Criteria

I am a female who has not started menstruating or started less than 18 months ago.

I have been diagnosed with AIS.

My skeletal maturity is at a Risser stage of 0 to 2.

Exclusion Criteria

I am experiencing symptoms of a neurological disorder.

I have a condition affecting my legs.

I have a heart condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a customized Providence brace designed using optimization and finite element analysis

2 years

Regular visits for brace fitting and adjustments

Follow-up

Participants are monitored for changes in Cobb angle and quality of life

2 years

Annual visits for radiographic analysis and QoL assessments

What Are the Treatments Tested in This Trial?

Interventions

• Conventional Brace
• Optimized Brace

Trial Overview The study tests two types of braces for scoliosis: a conventional brace and an optimized brace designed using a new method tailored to each patient. The effectiveness of immediate correction by both braces and their long-term use will be compared.

How Is the Trial Designed?

Group I: Optimized Providence brace Experimental Treatment 3 Interventions

The braces will be designed using optimization and finite element analysis.

Group II: Conventional Providence brace Active Control 3 Interventions

The braces will be designed by an orthotist using the conventional design method.

Who Is Running the Clinical Trial?

St. Justine's Hospital

Lead Sponsor

Trials

205

Recruited

87,300+