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

Trial Summary

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+