NCT06380530 Advanced Surgical Simulation Processes in the Correction of Skeletal Defects and Deformities
| NCT ID | NCT06380530 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Ortopedico Rizzoli |
| Condition | Musculoskeletal Deformity |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-10-31 |
| Primary Completion | 2028-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-10-31 with a primary completion date of 2028-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Virtual Surgical Planning (VSP), Computer-Aided Surgical Simulation (CASS) for bone corrections, and the customization of implants and devices through 3D printing, known as Patient-Specific Instruments (PSI) and Graft-Specific Instruments (GSI), are assuming increasingly central roles in orthopedic clinical and surgical practice. One area witnessing notable advancement is the treatment of musculoskeletal disorders (MMS) in children, adolescents, and young adults. These disorders involve severe and rare abnormalities in skeletal formation and development across three-dimensional planes, often affecting multiple limbs. Managing such deformities is complex, challenging to standardize, and prone to unpredictable clinical, radiographic, and functional outcomes. The application of 3D modeling and printing technologies offers a deeper understanding of deformities and facilitates improved prediction, precision, reproducibility, and safety in surgical interventions. The Musculoskeletal Apparatus Network (RAMS Network) centers are equipped with advanced 3D laboratories for surgical simulation and planning, aligned with the overarching goal of improving surgery quality through "in-silico" medicine (ISM) principles. At present, numerous complex surgeries involving Virtual Surgical Planning (VSP) and sterilizable 3D-printed Patient-Specific Instruments (PSI) and/or Graft-Specific Instruments (GSI) are being simulated and performed at the Rizzoli Institute. Preliminary data from previous protocols indicate a significant reduction in surgical time with the implementation of VSP and the utilization of PSI and GSI. The aim of this study is to enhance the current process of simulating, planning, and designing surgical support tools within 3D Printing Point-of-Care (3D POC) facilities. To achieve this, it is imperative to expand case volumes and systematically organize, categorize, and standardize simulation and planning procedures.
Eligibility 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
Contact & Investigator
Pierfrancesco Costici, MD
PRINCIPAL INVESTIGATOR
Ospedale Pediatrico Bambin Gesù
Frequently Asked Questions
Who can join the NCT06380530 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 40 Years, studying Musculoskeletal Deformity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06380530 currently recruiting?
Yes, NCT06380530 is actively recruiting participants. Contact the research team at graziachiara.menozzi@ior.it for enrollment information.
Where is the NCT06380530 trial being conducted?
This trial is being conducted at Bologna, Italy, Rozzano, Italy, Genova, Italy, Milan, Italy and 3 additional locations.
Who is sponsoring the NCT06380530 clinical trial?
NCT06380530 is sponsored by Istituto Ortopedico Rizzoli. The principal investigator is Pierfrancesco Costici, MD at Ospedale Pediatrico Bambin Gesù. The trial plans to enroll 100 participants.