3D and motion-informed guidance for choosing scoliosis surgery
Identification of Key Parameters to Initiate the Shift Towards 3D, Dynamic and Mechanically-informed Decision Making in Adolescent Idiopathic Scoliosis
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 10 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven, Vlaams-Brabant) |
| Trial ID | NCT04761549 on ClinicalTrials.gov |
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.
Who should consider this trial
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).
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Leuven, Vlaams-Brabant
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.