3D and motion-informed guidance for choosing scoliosis surgery
Official title: Identification of Key Parameters to Initiate the Shift Towards 3D, Dynamic and Mechanically-informed Decision Making in Adolescent Idiopathic Scoliosis
Run by Universitaire Ziekenhuizen KU Leuven · NCT04761549 · Data updated 2026-11-12
This project will try using 3D imaging and movement-based mechanical information to help decide between vertebral body tethering or spinal fusion for adolescents and young adults with idiopathic scoliosis treated at UZ Leuven.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 10 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven, Vlaams-Brabant) |
| Status | Recruiting |
| Started | January 19, 2021 |
| Main results expected | January 2027 |
| Study ends | January 2027 |
| Registry record updated | March 9, 2026 |
| Trial ID | NCT04761549 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients aged 10–35 with adolescent idiopathic scoliosis who are scheduled for vertebral body tethering or selective fusion at UZ Leuven and can give informed consent (or have guardian consent).
✕Probably not a fit
Patients who have already had prior spinal fusion or tethering, who have severe comorbid illnesses affecting surgical outcome, or those not treated at the study center are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will enroll patients aged 10–35 with adolescent idiopathic scoliosis who are scheduled for vertebral body tethering or selective fusion at UZ Leuven. They will collect 3D imaging and dynamic/biomechanical data and apply mechanically informed models to guide selection of fusion levels or tethering strategies. Surgical plans informed by these data will be recorded and patients will be followed for clinical and radiographic outcomes. The goal is to determine whether adding dynamic and mechanical information changes surgical decision-making and early outcomes compared with current practice.
Why it matters
Potential benefit: If successful, this approach could lead to more precise surgery choices that better preserve spinal motion and reduce unnecessary fusions.
How similar studies have gone: Vertebral body tethering has shown promising short-term results but long-term outcomes are limited, and mechanically informed, dynamic decision tools for scoliosis surgery remain relatively novel with limited prior evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient diagnosed with Adolescent Idiopathic Scoliosis * 10-35 years old * Patient is scheduled to be surgically treated by vertebral body tethering (VBT) or selective fusion at UZ Leuven * Informed consent obtained: also from parent/guardian in case of minors Exclusion Criteria: * Patient has undergone a fusion or VBT procedure before * Patient has a severe underlying illness which might influence the outcome of the surgery * Making it reasonable for the investigator to exclude the patient
Where it's running
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UZ Leuven
Leuven, Vlaams-Brabant, Belgium Recruiting
Study contacts
- Principal investigator: Sebastiaan Schelfaut — Universitaire Ziekenhuizen KU Leuven
- Study coordinator: Sebastiaan Schelfaut
- Email: sebastiaan.schelfaut@uzleuven.be
- Phone: +32 16 34 08 73
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Comfort Tote to help recovery after scoliosis surgery in teens
This study tests whether a therapeutic Comfort Tote can reduce pain and anxiety after surgery for adolescent idiopathic scoliosis.
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Erector spinae plane block to reduce post-operative pain after posterior spinal fusion in children
This will try giving an erector spinae plane block with ropivacaine to see if it reduces pain and the need for opioid pain medicine after posterior spinal fusion in children with adolescent idiopathic or neuromuscular scoliosis.
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MRI-guided dynamic support for correcting adolescent scoliosis
This pilot tests whether an MRI-compatible air-padded support with programmable pneumatic control can quickly reduce spinal curvature in 10–16-year-olds with mild to moderate adolescent idiopathic scoliosis.
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This study tests whether the Momentum Spine app can reliably detect scoliosis progression in 8-18 year olds without radiographs and guide follow-up care.
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Examining how spinal manipulation affects motor control in adolescents with scoliosis
This study is testing how spinal manipulation affects movement control in teenagers with scoliosis to see if it helps them improve their balance and muscle function.
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Using a 3D camera to assess scoliosis in adolescents
This study is testing a new way to check the spine of teenagers with scoliosis using a special 3D camera to see if it’s better and safer than traditional X-rays.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.