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
Led by Istituto Ortopedico Rizzoli · Updated on 2025-12-26
100
Participants Needed
7
Research Sites
52 weeks
Total Duration
I
Istituto Ortopedico Rizzoli
Lead Sponsor
O
Ospedale Pediatrico Bambino Gesù
Collaborating Sponsor
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
Advanced Surgical Simulation Processes in the Correction of Skeletal Defects and Deformities
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You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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)
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
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
G
Grazia Chiara Menozzi
G
Giovanni Trisolino, MD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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