Using advanced surgical simulation to correct skeletal defects in children
Advanced Surgical Simulation Processes in the Correction of Skeletal Defects and Deformities
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 2 Years to 40 Years |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Locations | 7 sites (Bologna, BO and 6 other locations) |
| Trial ID | NCT06380530 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are children and adolescents diagnosed with musculoskeletal diseases requiring surgical correction of limb deformities.
Not a fit: Patients who are pregnant, lactating, or those who refuse to participate in the study will not benefit from this intervention.
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 performed: Other studies utilizing 3D modeling and surgical simulation have shown promising results, indicating that this approach is gaining traction in orthopedic practices.
Eligibility criteria
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 this trial is running
Bologna, BO and 6 other locations
- 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)
- Ospedale Pediatrico Bambino Gesù — Roma, Italy (Not_yet_recruiting)
Study contacts
- Principal investigator: Pierfrancesco Costici, MD — Ospedale Pediatrico Bambin Gesù
- Study coordinator: Grazia Chiara Menozzi
- Email: graziachiara.menozzi@ior.it
- Phone: 0516366
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.