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NCT06380530

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

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-31

Study Completion Date

2029-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Musculoskeletal Deformity Musculoskeletal Abnormalities Musculoskeletal Disorder

Keywords

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

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pediatric patients with musculoskeletal diseases

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.

Group Type EXPERIMENTAL

Deformity correction

Intervention Type PROCEDURE

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

Interventions

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Deformity correction

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierfrancesco Costici, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale Pediatrico Bambin Gesù

Giorgio Marrè Brunenghi, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Giannina Gaslini

Fabio Verdoni, MD

Role: PRINCIPAL_INVESTIGATOR

Galeazzi Orthopedic Institute

Roberto Biagini, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Nazionale Tumori Regina Elena

Gianluigi Pasta, MD

Role: PRINCIPAL_INVESTIGATOR

Policlinico San Matteo

Tommaso Bonanzinga, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Clinico Humanitas

Locations

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IRCCS Istituto Ortopedico Rizzoli

Bologna, BO, Italy

Site Status RECRUITING