Actively Recruiting
Prospective Multicenter Evaluation of a New Predictive Model for the Progression of Adolescent Idiopathic Scoliosis
Led by St. Justine's Hospital · Updated on 2024-04-17
1200
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
Sponsors
S
St. Justine's Hospital
Lead Sponsor
Q
Queen Mary Hospital, Hong Kong
Collaborating Sponsor
AI-Summary
What this Trial Is About
Scoliosis is a three-dimensional deformity that changes the spine's shape and position. The most common type, adolescent idiopathic scoliosis (AIS), affects mainly young adolescent females and can require bracing or surgery to prevent worsening. Researchers have developed a predictive model using 3D spinal measurements to better estimate curve progression in AIS. This study aims to refine and test this model in a larger group to help guide treatment decisions more accurately. The study uses a new low-dose biplanar X-ray system (EOS) to take stereo-radiographs and create 3D reconstructions of the spine and pelvis. These images help measure vertebrae, disks, and pelvic geometry in detail. Patients may receive usual treatments like bracing or surgery if needed, with bracing compliance monitored using special sensors. Surgical patients will have their data analyzed but leave the study after surgery. The goal is to validate the model by comparing the new 3D measurements with traditional methods over time. Participants will be followed for up to 24 months with visits ideally every 6 months, including physical exams, growth and maturity assessments, and X-rays without braces at least annually. The study collects detailed data at each visit to track scoliosis severity and curve changes using 3D spine reconstructions. Researchers will analyze these measurements to improve predictions of scoliosis progression and help identify which patients need early treatment to avoid surgery.
CONDITIONS
Brief Title
Prospective Multicenter Evaluation of a New Predictive Model for the Progression of Adolescent Idiopathic Scoliosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with idiopathic scoliosis by a surgeon
- Age between 10 and 15 years at recruitment
- Spina bifida occulta without neurological signs and otherwise normal
- Cobb angle curve between 11º and 40º
- Risser score of 0 or 1 on standing spine X-ray
- Includes single thoracic, thoraco-lumbar, lumbar, double major, and triple major curves
You will not qualify if you...
- Previous surgery on thoracic, pelvis, or spine areas
- Congenital scoliosis
- MRI abnormalities such as Syrinx > 4mm or Chiari malformation
- Syndromic scoliosis linked to genetic syndromes like Marfan's
- Neuromuscular scoliosis
- Developmental delay
- Spinal asymmetry
- Symptomatic spondylolisthesis
- Leg length difference greater than 1 cm
- Unable or unwilling to commit to required follow-up visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants undergo regular assessments including body measurements, sexual maturity status updates, and spine radiographs without brace to monitor scoliosis progression.
Follow-up visits approximately every 6 months; spine radiographs at least once every 12 months without brace
Trial Site Locations
Total: 9 locations
1
Rady Children's Hospital
San Diego, California, United States, 92123
Actively Recruiting
2
Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States, 19803
Not Yet Recruiting
3
Miami Children's Hospital
Miami, Florida, United States, 33155
Not Yet Recruiting
4
Mayo Clinic
Minneota, Minnesota, United States, MN 55902
Not Yet Recruiting
5
St Justine's Hospital
Montreal, Quebec, Canada, H3T 1C4
Actively Recruiting
6
Robert Debré Hospital
Paris, France, 75019
Not Yet Recruiting
7
Queen Mary Hospital
Hong Kong, Hong Kong
Actively Recruiting
8
The Meijo Hospital
Nagoya, Japan
Actively Recruiting
9
National University
Singapore, Singapore
Not Yet Recruiting
Research Team
S
Stefan Parent, MD, PhD
M
Marjolaine Roy-Beaudry
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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