Musculoskeletal Abnormalities, Musculoskeletal Deformity, Musculoskeletal Disorder
Conditions
Keywords
Virtual Surgical Planning, Patient-Specific instrument, Graft-Specific instrument, Pediatric Orthopedics
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.
Interventions
PROCEDUREDeformity correction
Surgeries to correct bone defomity, supported by the use of preoperative planning and/or patient-specific instruments
Sponsors
Ospedale Pediatrico Bambino Gesù
Istituto Giannina Gaslini
Galeazzi Orthopedic Institute
Istituto Nazionale Tumori Regina Elena
Policlinico San Matteo
Istituto Clinico Humanitas
Istituto Ortopedico Rizzoli
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Achieved skeletal corrections | At baseline (day 0) | Assessment of achieved skeletal corrections compared to planned corrections, measured on standard radiographs or CT scans depending on the type of deformity corrected |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operating room times | At baseline (day 0) | Operating room times for each planned procedure |
| Fluoroscopy times | At baseline (day 0) | Fluoroscopy times for each planned procedure |
| Blood loss | At baseline (day 0) | Blood loss for each patient |
| Intra- and peri-operative complications | At baseline (day 0) | Intra- and peri-operative complications for each patient |
| Suitability of GSIs | At baseline (day 0) | Suitability of GSIs, if needed, in relation to the planned surgery |
| Suitability of bone graft | At baseline (day 0) | Suitability of bone graft, if needed, in relation to the planned surgery |
| Clinical-functional outcome | At baseline (day 0) | 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 |
| Suitability of PSIs | At baseline (day 0) | Suitability of PSIs in relation to the planned surgery |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cost analysis | At baseline (day 0) | 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. |
Countries
Italy
Contacts
Primary ContactGrazia Chiara Menozzi
Backup ContactGiovanni Trisolino, MD
Outcome results
None listed