Actively Recruiting
Identification of Key Parameters to Initiate the Shift Towards 3D, Dynamic and Mechanically-informed Decision Making in Adolescent Idiopathic Scoliosis
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2026-03-09
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Adolescent Idiopathic Scoliosis (AIS) is a spinal growth defect mostly affecting prepubertal children aged 10 to 14 years, causing lateral curves and rotations of the spine. AIS can lead to posture problems, back pain, and visible asymmetry, such as uneven shoulders. Early diagnosis and proper treatment are important to stop curve progression and reduce related health issues. Current surgical decisions rely on two-dimensional X-rays, which may not capture the full three-dimensional and dynamic nature of the spine's deformity, leading to suboptimal outcomes and revision surgeries. Treatment options include wearing a brace for immature patients with curves between 25 and 40 degrees. If the curve does not respond and growth potential remains, vertebral body tethering (VBT), a minimally invasive FDA-approved device that gradually corrects scoliosis by slowing growth on one side, may be considered. For curves of 50 degrees or more with little growth left, spinal fusion surgery is recommended to permanently correct the spine by attaching vertebrae with surgical hardware. The study aims to improve surgical planning by using 3D dynamic and mechanical information from musculoskeletal models, moving beyond current 2D static assessments. Participants will undergo questionnaires, radiological EOS scans, and 3D dynamic motion analyses to gather detailed data on spinal deformity and mechanics. Researchers will measure 3D dynamic parameters up to two years after surgery and develop biomechanically-informed 3D models specific to AIS. This approach hopes to help surgeons make evidence-based decisions, improve patient outcomes, reduce complications, and lower the costs associated with AIS treatment. The study is sponsored by Universitaire Ziekenhuizen KU Leuven and involves patients aged 10 to 35 undergoing VBT or selective fusion surgery.
CONDITIONS
Brief Title
3D, Dynamic and Mechanically-informed Decision Making in AIS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient diagnosed with Adolescent Idiopathic Scoliosis
- Aged 10 to 35 years
- Scheduled for vertebral body tethering (VBT) or selective fusion surgery at UZ Leuven
- Informed consent obtained, including from parent/guardian for minors
You will not qualify if you...
- Previous fusion or vertebral body tethering surgery
- Severe underlying illness that might affect surgery outcome
- Investigator's discretion to exclude patient for other reasons
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 2 years post-operatively
Participants undergo questionnaires, radiological EOS scans, and 3D dynamic motion analysis to gather detailed 3D dynamic and mechanical information about the spine.
Multiple visits over 2 years post-operatively
Trial Site Locations
Total: 1 location
1
UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
Research Team
S
Sebastiaan Schelfaut
L
Lennart Scheys
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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