Clinical trial NCT06380530: Advanced Surgical Simulation Processes in the Correction of Skeletal Defects and Deformities
Official title: Advanced Surgical Simulation Processes in the Correction of Skeletal Defects and Deformities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Musculoskeletal Deformity
Musculoskeletal Abnormalities
Musculoskeletal Disorder
Keywords: Virtual Surgical Planning
Patient-Specific instrument
Graft-Specific instrument
Pediatric Orthopedics
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
Collaborators: name: Ospedale Pediatrico Bambino Gesù
name: Istituto Giannina Gaslini
name: Galeazzi Orthopedic Institute
name: Istituto Nazionale Tumori Regina Elena
name: Policlinico San Matteo
name: Istituto Clinico Humanitas
First posted: 2024-04-24
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Achieved skeletal corrections
timeFrame: At baseline (day 0)
measure: Achieved skeletal corrections
timeFrame: After 1 year
Secondary outcomes:
measure: Operating room times
timeFrame: At baseline (day 0)
measure: Fluoroscopy times
timeFrame: At baseline (day 0)
measure: Blood loss
timeFrame: At baseline (day 0)
measure: Intra- and peri-operative complications
timeFrame: At baseline (day 0)
measure: Suitability of PSIs
timeFrame: At baseline (day 0)
measure: Suitability of GSIs
timeFrame: At baseline (day 0)
measure: Suitability of bone graft
timeFrame: At baseline (day 0)
measure: Clinical-functional outcome
timeFrame: At baseline (day 0)
measure: Clinical-functional outcome
timeFrame: After 1 year
Other outcomes:
measure: Cost analysis
timeFrame: At baseline (day 0)
Locations:
city: Bologna
country: Italy
facility: IRCCS Istituto Ortopedico Rizzoli
state: BO
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: MI
city: Genova
country: Italy
facility: Istituto Giannina Gaslini
city: Milano
country: Italy
facility: Galeazzi Orthopedic Institute
city: Pavia
country: Italy
facility: Policlinico San Matteo
city: Roma
country: Italy
facility: Istituto Nazionale Tumori Regina Elena
city: Roma
country: Italy
facility: Ospedale Pediatrico Bambino Gesù
Study officials:
affiliation: Ospedale Pediatrico Bambin Gesù
name: Pierfrancesco Costici, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Istituto Giannina Gaslini
name: Giorgio Marrè Brunenghi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Galeazzi Orthopedic Institute
name: Fabio Verdoni, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Istituto Nazionale Tumori Regina Elena
name: Roberto Biagini, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Policlinico San Matteo
name: Gianluigi Pasta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Istituto Clinico Humanitas
name: Tommaso Bonanzinga, MD
role: PRINCIPAL_INVESTIGATOR
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