Personalized medicine. Closing the gap between knowledge and clinical practice.
Juan-Manuel Anaya, Carolina Duarte-Rey, Juan C Sarmiento-Monroy...
https://pubmed.ncbi.nlm.nih.gov/27302209Actively Recruiting
Phase Not Applicable
Age: 2Years - 40Years
All Genders
ID06380530
Advanced Surgical Simulation and 3D-Printed Patient-Specific Instruments for Correction of Skeletal Defects and Deformities in Children, Adolescents, and Young Adults
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
Researchers are investigating advanced surgical simulation techniques to correct skeletal defects and deformities in children, adolescents, and young adults with musculoskeletal disorders. These disorders involve complex and rare abnormalities in bone formation and growth, often affecting multiple limbs and requiring precise correction. The study focuses on improving surgical outcomes by using Virtual Surgical Planning (VSP), Computer-Aided Surgical Simulation (CASS), and customized implants and surgical tools created through 3D printing. The intervention involves surgeries to correct bone deformities using preoperative planning and patient-specific instruments such as sterilizable 3D-printed devices tailored to each patient's anatomy. These advanced tools and simulations aim to enhance the accuracy, safety, and reproducibility of surgical procedures. The study is conducted at specialized centers equipped with 3D laboratories designed for detailed surgical simulation and planning. Participants will undergo assessments to measure skeletal corrections at the start of the study and after one year. Researchers will monitor surgical time and the quality of corrections achieved using the innovative 3D planning methods. The goal is to expand and standardize surgical simulation procedures to improve treatment quality. The study includes ongoing follow-up with radiological exams to evaluate surgical outcomes over time.
CONDITIONS
Official Title
Advanced Surgical Simulation Processes in the Correction of Skeletal Defects and Deformities
Who Can Participate
Age: 2Years - 40Years
All Genders
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
1
2
3
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
Frequently Asked Questions
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