Actively Recruiting
Advanced Surgical Simulation Processes in the Correction of Skeletal Defects and Deformities
Led by Istituto Ortopedico Rizzoli · Updated on 2025-12-26
100
Participants Needed
7
Research Sites
234 weeks
Total Duration
On this page
Sponsors
I
Istituto Ortopedico Rizzoli
Lead Sponsor
O
Ospedale Pediatrico Bambino Gesù
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Advanced Surgical Simulation Processes in the Correction of Skeletal Defects and Deformities
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Patients who refuse to participate in the study
- Patients who do not undergo radiological follow-up examinations for VSP or have insufficient radiological records for VSP
- Patients undergoing other interventions for MSD correction such as growth modulation by epiphysiodesis, hemiepiphysiodesis, or external fixation
- Pregnant or lactating women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
IRCCS Istituto Ortopedico Rizzoli
Bologna, BO, Italy, 40136
Actively Recruiting
2
Istituto Clinico Humanitas
Rozzano, MI, Italy
Not Yet Recruiting
3
Istituto Giannina Gaslini
Genova, Italy
Not Yet Recruiting
4
Galeazzi Orthopedic Institute
Milan, Italy
Not Yet Recruiting
5
Policlinico San Matteo
Pavia, Italy
Not Yet Recruiting
6
Istituto Nazionale Tumori Regina Elena
Roma, Italy
Not Yet Recruiting
7
Ospedale Pediatrico Bambino Gesù
Roma, Italy
Not Yet Recruiting
Research Team
G
Grazia Chiara Menozzi
CONTACT
G
Giovanni Trisolino, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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