Actively Recruiting

Phase Not Applicable
Age: 2Years - 40Years
All Genders
ID06380530

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

52 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

Researchers are evaluating advanced surgical simulation techniques for correcting complex skeletal deformities and abnormalities in children, adolescents, and young adults with musculoskeletal disorders. These conditions often involve rare and severe abnormalities in bone, joint, and muscle-tendon development, affecting multiple limbs and presenting challenges in standardizing treatment and predicting outcomes. The study focuses on improving surgical planning and support tools using 3D modeling and printing technologies, aiming to enhance precision, safety, and reproducibility of surgeries. The study involves surgeries to correct bone deformities, supported by preoperative virtual surgical planning and the use of patient-specific instruments created through 3D printing. These include Patient-Specific Instruments (PSI) and Graft-Specific Instruments (GSI), which are designed to improve surgical accuracy. The research is conducted within specialized 3D laboratories at the Musculoskeletal Apparatus Network centers, where surgical simulations and planning procedures are systematically organized and standardized. Participants will undergo assessments including radiological follow-up and clinical-functional evaluations at the time of surgery and after one year. Researchers will measure outcomes such as the degree of skeletal correction achieved, operating room times, fluoroscopy times, blood loss, and any intra- or peri-operative complications. The suitability of the patient-specific instruments and bone grafts will also be evaluated. The study aims to improve surgical quality and efficiency while monitoring participants throughout a one-year period post-surgery.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 2Years - 40Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of musculoskeletal disease of the limbs
  • Need for one or more osteotomies for bone correction
  • Signed consent to participate in the trial
Not Eligible

You will not qualify if you...

  • Refusal to participate in the study
  • Lack of radiological follow-up or insufficient radiological data for planning
  • Undergoing other correction interventions such as growth modulation or external fixation
  • Pregnant or lactating women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery and Immediate Post-operative Care

Duration - Day 0

Participants undergo surgeries to correct bone deformities supported by preoperative planning and/or patient-specific instruments, followed by immediate post-operative care.

1 surgical visit (in-person)

Post-operative Follow-up

Duration - Up to 1 year

Participants are followed up to assess skeletal corrections and clinical-functional outcomes after surgery.

Follow-up visits over 1 year

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

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Research Team

G

Grazia Chiara Menozzi

G

Giovanni Trisolino, MD

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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Published Research Related To This Trial

Custom Massive Allograft in a Case of Pelvic Bone Tumour: Simulation of Processing with Computerised Numerical Control vs. Robotic Machining.

Leonardo Vivarelli, Marco Govoni, Dario Attala...

https://pubmed.ncbi.nlm.nih.gov/35628908

The effect of three-dimensional (3D) printing on quantitative and qualitative outcomes in paediatric orthopaedic osteotomies: a systematic review.

Mohsen Raza, Daniel Murphy, Yael Gelfer

https://pubmed.ncbi.nlm.nih.gov/33828856

Design Techniques to Optimize the Scaffold Performance: Freeze-dried Bone Custom-made Allografts for Maxillary Alveolar Horizontal Ridge Augmentation.

Felice Roberto Grassi, Roberta Grassi, Leonardo Vivarelli...

https://pubmed.ncbi.nlm.nih.gov/32204393

In-House, Fast FDM Prototyping of a Custom Cutting Guide for a Lower-Risk Pediatric Femoral Osteotomy.

Leonardo Frizziero, Gian Maria Santi, Christian Leon-Cardenas...

https://pubmed.ncbi.nlm.nih.gov/34073324

Virtual Surgical Planning, 3D-Printing and Customized Bone Allograft for Acute Correction of Severe Genu Varum in Children.

Giulia Alessandri, Leonardo Frizziero, Gian Maria Santi...

https://pubmed.ncbi.nlm.nih.gov/36556271