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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Surgeries to correct bone defomity, supported by the use of preoperative planning and/or patient-specific instruments
IRCCS Istituto Ortopedico Rizzoli
Bologna, BO, Italy
RECRUITINGIstituto Clinico Humanitas
Rozzano, MI, Italy
NOT_YET_RECRUITINGIstituto Giannina Gaslini
Genova, Italy
NOT_YET_RECRUITINGGaleazzi Orthopedic Institute
Milan, Italy
NOT_YET_RECRUITINGPoliclinico San Matteo
Pavia, Italy
NOT_YET_RECRUITINGIstituto Nazionale Tumori Regina Elena
Roma, Italy
NOT_YET_RECRUITINGOspedale Pediatrico Bambino Gesù
Roma, Italy
NOT_YET_RECRUITINGAchieved 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
Time frame: At baseline (day 0)
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
Time frame: After 1 year
Operating room times
Operating room times for each planned procedure
Time frame: At baseline (day 0)
Fluoroscopy times
Fluoroscopy times for each planned procedure
Time frame: At baseline (day 0)
Blood loss
Blood loss for each patient
Time frame: At baseline (day 0)
Intra- and peri-operative complications
Intra- and peri-operative complications for each patient
Time frame: At baseline (day 0)
Suitability of PSIs
Suitability of PSIs in relation to the planned surgery
Time frame: At baseline (day 0)
Suitability of GSIs
Suitability of GSIs, if needed, in relation to the planned surgery
Time frame: At baseline (day 0)
Suitability of bone graft
Suitability of bone graft, if needed, in relation to the planned surgery
Time frame: At baseline (day 0)
Clinical-functional outcome
Clinical-functional outcome will be assessed by preoperative and one-year follow-up administration of the Pediatric Outcome Data Collection Instrument (PODCI) questionnaire for pediatric patients or the Short Form Health Survey 36 (SF-36) for young adults
Time frame: At baseline (day 0)
Clinical-functional outcome
Clinical-functional outcome will be assessed by preoperative and one-year follow-up administration of the Pediatric Outcome Data Collection Instrument (PODCI) questionnaire for pediatric patients or the Short Form Health Survey 36 (SF-36) for young adults
Time frame: After 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.