Advanced Surgical Simulation Processes in the Correction of Skeletal Defects and Deformities

Обзор

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.

Вмешательства

• Процедура Deformity correction
  Surgeries to correct bone defomity, supported by the use of preoperative planning and/or patient-specific instruments

Первичные конечные точки

• Achieved skeletal corrections [Срок оценки: At baseline (day 0)]
• Achieved skeletal corrections [Срок оценки: After 1 year]

Вторичные конечные точки (9)

• Operating room times [Срок оценки: At baseline (day 0)]
• Fluoroscopy times [Срок оценки: At baseline (day 0)]
• Blood loss [Срок оценки: At baseline (day 0)]
• Intra- and peri-operative complications [Срок оценки: At baseline (day 0)]
• Suitability of PSIs [Срок оценки: At baseline (day 0)]
• Suitability of GSIs [Срок оценки: At baseline (day 0)]
• Suitability of bone graft [Срок оценки: At baseline (day 0)]
• Clinical-functional outcome [Срок оценки: At baseline (day 0)]
• Clinical-functional outcome [Срок оценки: After 1 year]

Критерии участия

Критерии включения

• 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;

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Италия · 7 центров

• IRCCS Istituto Ortopedico Rizzoli — Bologna
• Istituto Clinico Humanitas — Rozzano
• Istituto Giannina Gaslini — Genova
• Galeazzi Orthopedic Institute — Milan
• Policlinico San Matteo — Pavia
• Istituto Nazionale Tumori Regina Elena — Roma
• Ospedale Pediatrico Bambino Gesù — Roma

Публикации

• 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.
• 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.
• 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.
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Идентификаторы

NCT: NCT06380530 · SIMULA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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