About this trial
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
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Deformity correction
Procedure/SurgerySurgeries to correct bone defomity, supported by the use of preoperative planning and/or patient-specific instruments
Treatment groups
Trial outcomes
Primary outcomes
Achieved skeletal corrections
Assessment of achieved skeletal corrections compared to planned corrections, measured on standard radiographs or CT scans depending on the type of deformity corrected
Achieved skeletal corrections
Assessment of achieved skeletal corrections compared to planned corrections, measured on standard radiographs or CT scans depending on the type of deformity corrected
Secondary outcomes
Operating room times
Operating room times for each planned procedure
Fluoroscopy times
Fluoroscopy times for each planned procedure
Blood loss
Blood loss for each patient
Intra- and peri-operative complications
Intra- and peri-operative complications for each patient
Other outcomes
Cost analysis
The cost analysis will entail evaluating expenses associated with various components, including imaging required for planning, production of 3D-printed instrumentation such as PSIs and GSIs, and bone grafts. Additionally, human costs for planning will be considered. Surgical-related costs will be assessed by comparing them with those of traditional surgeries to gauge the cost-effectiveness of the procedure, taking into account the achieved correction and the necessity for additional procedures.
Sponsors and contacts
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Istituto Ortopedico Rizzoli
Lead sponsor
Ospedale Pediatrico Bambino Gesù
Collaborator
Istituto Giannina Gaslini
Collaborator
Galeazzi Orthopedic Institute
Collaborator
Istituto Nazionale Tumori Regina Elena
Collaborator
Policlinico San Matteo
Collaborator
Istituto Clinico Humanitas
Collaborator