Actively Recruiting
Advanced Surgical Simulation Using 3D Planning and Custom Instruments for Correction of Bone 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
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
Eligibility Criteria
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
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
Research Team
G
Grazia Chiara Menozzi
G
Giovanni Trisolino, MD
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