Using advanced surgical simulation to correct skeletal defects in children
Official title: Advanced Surgical Simulation Processes in the Correction of Skeletal Defects and Deformities
Run by Istituto Ortopedico Rizzoli · NCT06380530 · Data updated 2026-11-12
This study is testing a new way to use 3D technology to help doctors perform safer and more precise surgeries to fix bone problems in children and young adults.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 2 Years to 40 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Locations | 7 sites (Bologna, BO and 6 other locations) |
| Status | Recruiting |
| Started | October 31, 2024 |
| Main results expected | May 2028 |
| Study ends | May 2029 |
| Registry record updated | November 10, 2026 |
| Trial ID | NCT06380530 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children and adolescents diagnosed with musculoskeletal diseases requiring surgical correction of limb deformities.
✕Probably not a fit
Patients who are pregnant, lactating, or those who refuse to participate in the study will not benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study focuses on the use of Virtual Surgical Planning (VSP) and Computer-Aided Surgical Simulation (CASS) to improve the correction of musculoskeletal deformities in children and young adults. By utilizing 3D modeling and printing technologies, the study aims to create patient-specific and graft-specific instruments that enhance surgical precision and outcomes. The approach seeks to standardize complex surgical interventions, making them safer and more predictable for patients with severe skeletal abnormalities.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and safer surgical corrections for children with musculoskeletal disorders.
How similar studies have gone: Other studies utilizing 3D modeling and surgical simulation have shown promising results, indicating that this approach is gaining traction in orthopedic practices.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of musculoskeletal disease (MSD) of the limbs; * Need for mono- or polyaxial correction by one or more osteotomies; * Presence of specific consent to participate in the trial; Exclusion Criteria: * Patients who refuse to participate in the study * Patients who do not undergo radiological follow-up examinations for VSP or for whom the radiological record is insufficient to conduct VSP; * Patients who undergo different interventions for correction of MSD (growth modulation interventions by epiphysiodesis and hemiepiphysiodesis, progressive correction by external circular/hexapodal fixation); * Pregnant or lactating women
Where it's running
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IRCCS Istituto Ortopedico Rizzoli
Bologna, Bo, Italy Recruiting -
Istituto Clinico Humanitas
Rozzano, Mi, Italy Not yet recruiting -
Istituto Giannina Gaslini
Genova, Italy Not yet recruiting -
Galeazzi Orthopedic Institute
Milan, Italy Not yet recruiting -
Policlinico San Matteo
Pavia, Italy Not yet recruiting -
Istituto Nazionale Tumori Regina Elena
Roma, Italy Not yet recruiting
Show 1 more location
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Ospedale Pediatrico Bambino Gesù
Roma, Italy Not yet recruiting
Study contacts
- Principal investigator: Pierfrancesco Costici, MD — Ospedale Pediatrico Bambin Gesù
- Study coordinator: Giovanni Trisolino, MD
- Email: giovanni.trisolino@ior.it
- Phone: 0516366
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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.