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| Name | Class |
|---|---|
| Ospedale Pediatrico Bambino Gesù | UNKNOWN |
| Istituto Giannina Gaslini | OTHER |
| Galeazzi Orthopedic Institute | UNKNOWN |
| Istituto Nazionale Tumori Regina Elena |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pediatric patients with musculoskeletal diseases | Experimental | Children, adolescents, and young adults suffering from musculoskeletal disorders (MMD) who exhibit complex conditions characterized by rare and severe anomalies in skeletal development. These abnormalities may affect bones, joints, and musculotendinous structures. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deformity correction | Procedure | Surgeries to correct bone defomity, supported by the use of preoperative planning and/or patient-specific instruments |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | After 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Operating room times | Operating room times for each planned procedure | At baseline (day 0) |
| Fluoroscopy times | Fluoroscopy times for each planned procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Grazia Chiara Menozzi | Contact | 0516366 | 484 | graziachiara.menozzi@ior.it |
| Giovanni Trisolino, MD | Contact | 0516366 | 484 | giovanni.trisolino@ior.it |
| Name | Affiliation | Role |
|---|---|---|
| Pierfrancesco Costici, MD | Ospedale Pediatrico Bambin Gesù | Principal Investigator |
| Giorgio Marrè Brunenghi, MD | Istituto Giannina Gaslini | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Istituto Ortopedico Rizzoli | Recruiting | Bologna | BO | 40136 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | R. Michaels et al., "3D printing in surgical simulation: emphasized importance in the COVID-19 pandemic era," https://doi.org/10.2217/3dp-2021-0009, vol. 5, no. 1, pp. 5-9, May 2021, doi: 10.2217/3DP-2021-0009. | ||
| Background | S. Dash, S. K. Shakyawar, M. Sharma, and S. Kaushik, "Big data in healthcare: management, analysis and future prospects," J Big Data, vol. 6, no. 1, pp. 1-25, Dec. 2019, doi: 10.1186/S40537-019-0217-0/FIGURES/6. | ||
| Background | G. Pravettoni and S. Triberti, "A 'P5' Approach to Healthcare and Health Technology," P5 eHealth: An Agenda for the Health Technologies of the Future, pp. 3-17, 2020, doi: 10.1007/978-3-030-27994-3_1. | ||
| 27302209 | Background | Anaya JM, Duarte-Rey C, Sarmiento-Monroy JC, Bardey D, Castiblanco J, Rojas-Villarraga A. Personalized medicine. Closing the gap between knowledge and clinical practice. Autoimmun Rev. 2016 Aug;15(8):833-42. doi: 10.1016/j.autrev.2016.06.005. Epub 2016 Jun 11. |
| Label | URL |
|---|---|
| Customized Bone Allografts by 3D-printing (3D-MALF 2 protocol) | View source |
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| ID | Term |
|---|---|
| D009139 | Musculoskeletal Abnormalities |
| D009140 | Musculoskeletal Diseases |
| ID | Term |
|---|---|
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| UNKNOWN |
| Policlinico San Matteo | UNKNOWN |
| Istituto Clinico Humanitas | OTHER |
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| At baseline (day 0) |
| Blood loss | Blood loss for each patient | At baseline (day 0) |
| Intra- and peri-operative complications | Intra- and peri-operative complications for each patient | At baseline (day 0) |
| Suitability of PSIs | Suitability of PSIs in relation to the planned surgery | At baseline (day 0) |
| Suitability of GSIs | Suitability of GSIs, if needed, in relation to the planned surgery | At baseline (day 0) |
| Suitability of bone graft | Suitability of bone graft, if needed, in relation to the planned surgery | 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 | 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 | After 1 year |
| At baseline (day 0) |
| Fabio Verdoni, MD |
| Galeazzi Orthopedic Institute |
| Principal Investigator |
| Roberto Biagini, MD | Istituto Nazionale Tumori Regina Elena | Principal Investigator |
| Gianluigi Pasta, MD | Policlinico San Matteo | Principal Investigator |
| Tommaso Bonanzinga, MD | Istituto Clinico Humanitas | Principal Investigator |
| Istituto Clinico Humanitas | Not yet recruiting | Rozzano | MI | Italy |
|
| Istituto Giannina Gaslini | Not yet recruiting | Genova | Italy |
|
| Galeazzi Orthopedic Institute | Not yet recruiting | Milan | Italy |
|
| Policlinico San Matteo | Not yet recruiting | Pavia | Italy |
|
| Istituto Nazionale Tumori Regina Elena | Not yet recruiting | Roma | Italy |
|
| Ospedale Pediatrico Bambino Gesù | Not yet recruiting | Roma | Italy |
|
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