Actively Recruiting
Determining the Best Indications for Initiating Brace Treatment for Adolescent Idiopathic Scoliosis
Led by The University of Hong Kong · Updated on 2024-12-06
700
Participants Needed
2
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the cost-effectiveness of current bracing protocols for adolescent idiopathic scoliosis (AIS), focusing on whether early bracing at mild curve levels and surgery at 40 degrees provides better value while maintaining quality of life. This prospective study aims to improve decision-making and care for AIS patients by comparing different timing strategies for starting brace treatment. The study involves analyzing health quality of life using Scoliosis Research Society 22-item and EuroQol-5 dimension questionnaires alongside direct and indirect medical costs. The study includes AIS patients with remaining growth potential who are prescribed underarm (Boston) or Milwaukee braces. Data will be collected prospectively over at least two years with a minimum of five clinic visits, including clinical and radiographic assessments. Costs such as clinic visits, treatments, bracing fabrication, physiotherapy, psychological assessments, and surgery if needed will be analyzed. The study will also use mathematical modeling to simulate patient outcomes and identify the most cost-effective timing for brace initiation based on curve severity and maturity. Participants will undergo regular measurements of weight, height, arm span, radiographs, and doctor assessments at each visit. Quality of life and utility questionnaires will be completed at every visit. Researchers will monitor changes in spine curvature and posture, brace compliance, and health-related quality of life over up to three years. The study aims to provide evidence for the best balance of cost, quality of life, and treatment timing to guide care for AIS patients.
CONDITIONS
Brief Title
Determining Best Indications for Bracing for Adolescent Idiopathic Scoliosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with adolescent idiopathic scoliosis
- Seen in the first setting with remaining growth potential (Risser 0-2)
- Prescribed with either underarm (Boston) or Milwaukee bracing
You will not qualify if you...
- Patients not diagnosed with adolescent idiopathic scoliosis
- Unable to comply with study follow-up
- Refused consent for study participation
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 3 years
Participants undergo brace treatment for adolescent idiopathic scoliosis, which includes wearing either an underarm (Boston) or Milwaukee brace as prescribed.
At least 5 clinic visits over 2 years for weight, height, arm span measurements, radiographs, doctor assessments, and completion of quality of life questionnaires
Duration - Up to 3 years
Participants are monitored longitudinally to assess changes in scoliosis progression, brace compliance, quality of life, and cost-effectiveness outcomes.
At least 5 follow-up visits with clinical and radiographic assessments plus questionnaires
Trial Site Locations
Total: 2 locations
1
Duchess of Kent Children's Hospital
Hong Kong, Hong Kong
Actively Recruiting
2
Jason Pui Yin Cheung
Hong Kong, Hong Kong
Actively Recruiting
Research Team
J
Jason Cheung, MBBS, MS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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