protocolSection identificationModule nctId: NCT06380530, orgStudyIdInfo id: SIMULA, briefTitle: Advanced Surgical Simulation Processes in the Correction of Skeletal Defects and Deformities, acronym: SIMULA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2028-05, completionDateStruct date: 2029-05, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Istituto Ortopedico Rizzoli, class: OTHER, collaborators name: Ospedale Pediatrico Bambino Gesù, collaborators name: Istituto Giannina Gaslini, collaborators name: Galeazzi Orthopedic Institute, collaborators name: Istituto Nazionale Tumori Regina Elena, collaborators name: Policlinico San Matteo, collaborators name: Istituto Clinico Humanitas, descriptionModule briefSummary: 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., conditionsModule conditions: Musculoskeletal Deformity, conditions: Musculoskeletal Abnormalities, conditions: Musculoskeletal Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Deformity correction, outcomesModule primaryOutcomes measure: Achieved skeletal corrections, primaryOutcomes measure: Achieved skeletal corrections, secondaryOutcomes measure: Operating room times, secondaryOutcomes measure: Fluoroscopy times, secondaryOutcomes measure: Blood loss, secondaryOutcomes measure: Intra- and peri-operative complications, secondaryOutcomes measure: Suitability of PSIs, secondaryOutcomes measure: Suitability of GSIs, secondaryOutcomes measure: Suitability of bone graft, secondaryOutcomes measure: Clinical-functional outcome, secondaryOutcomes measure: Clinical-functional outcome, otherOutcomes measure: Cost analysis, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 40 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: IRCCS Istituto Ortopedico Rizzoli, city: Bologna, state: BO, zip: 40136, country: Italy, contacts name: Grazia Chiara Menozzi, role: CONTACT, phone: 0516266, phoneExt: 484, email: graziachiara.menozzi@ior.it, geoPoint lat: 44.49381, lon: 11.33875, locations facility: Istituto Clinico Humanitas, city: Rozzano, state: MI, country: Italy, geoPoint lat: 45.38193, lon: 9.1559, locations facility: Istituto Giannina Gaslini, city: Genova, country: Italy, contacts name: Giorgio Marrè Brunenghi, MD, role: CONTACT, email: giorgiomarre@gaslini.org, geoPoint lat: 44.40478, lon: 8.94438, locations facility: Galeazzi Orthopedic Institute, city: Milano, country: Italy, contacts name: Fabio Verdoni, MD, role: CONTACT, email: fabio.verdoni@grupposandonato.it, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Policlinico San Matteo, city: Pavia, country: Italy, contacts name: Gianluigi Pasta, MD, role: CONTACT, geoPoint lat: 45.19205, lon: 9.15917, locations facility: Istituto Nazionale Tumori Regina Elena, city: Roma, country: Italy, contacts name: Roberto Biagini, MD, role: CONTACT, email: roberto.biagini@ifo.it, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Ospedale Pediatrico Bambino Gesù, city: Roma, country: Italy, contacts name: Pier Francesco Costici, MD, role: CONTACT, email: pierfrancesco.costici@opbg.net, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False