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

NCT06380530 | Recruiting

• 1 other identifier: SIMULA
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 7

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.

Conditions

Musculoskeletal Deformity; Musculoskeletal Abnormalities; Musculoskeletal Disorder

Keywords

Virtual Surgical Planning; Patient-Specific instrument; Graft-Specific instrument; Pediatric Orthopedics

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (9)

• Operating room times

  At baseline (day 0)

• Fluoroscopy times

  At baseline (day 0)

• Blood loss

  At baseline (day 0)

• Intra- and peri-operative complications

  At baseline (day 0)

• Suitability of PSIs

  At baseline (day 0)

Other Outcomes (1)

• Cost analysis

  At baseline (day 0)

Study Arms (1)

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.

Procedure: Deformity correction

Interventions

Deformity correction PROCEDURE

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

Pediatric patients with musculoskeletal diseases

Eligibility Criteria

• Age: 2 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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 may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead
• Ospedale Pediatrico Bambino Gesù: collaborator
• Istituto Giannina Gaslini: collaborator
• Galeazzi Orthopedic Institute: collaborator
• Istituto Nazionale Tumori Regina Elena: collaborator
• Policlinico San Matteo: collaborator
• Istituto Clinico Humanitas: collaborator

Study Sites (7)

IRCCS Istituto Ortopedico Rizzoli

Bologna, BO, 40136, Italy

RECRUITING

Istituto Clinico Humanitas

Rozzano, MI, Italy

NOT YET RECRUITING

Istituto Giannina Gaslini

Genova, Italy

NOT YET RECRUITING

Galeazzi Orthopedic Institute

Milan, Italy

NOT YET RECRUITING

Policlinico San Matteo

Pavia, Italy

NOT YET RECRUITING

Istituto Nazionale Tumori Regina Elena

Roma, Italy

NOT YET RECRUITING

Ospedale Pediatrico Bambino Gesù

Roma, Italy

NOT YET RECRUITING

Related Publications (27)

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  BACKGROUND

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Related Links

• Customized Bone Allografts by 3D-printing (3D-MALF 2 protocol)

MeSH Terms

Conditions

Musculoskeletal Abnormalities; Musculoskeletal Diseases

Condition Hierarchy (Ancestors)

Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Pierfrancesco Costici, MD

  Ospedale Pediatrico Bambin Gesù

  PRINCIPAL INVESTIGATOR

• Giorgio Marrè Brunenghi, MD

  Istituto Giannina Gaslini

  PRINCIPAL INVESTIGATOR

• 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

Central Study Contacts

Grazia Chiara Menozzi

CONTACT

0516366; graziachiara.menozzi@ior.it

Giovanni Trisolino, MD

CONTACT

0516366; giovanni.trisolino@ior.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 24, 2024
• Study Start: October 31, 2024
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2029
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

IT (7)