Advanced Surgical Simulation Processes in the Correction of Skeletal Defects and Deformities
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Istituto Ortopedico Rizzoli
- Enrollment
- 100
- Locations
- 13
- Primary Endpoint
- Achieved skeletal corrections
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to 40 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Pediatric patients with musculoskeletal diseases
Children, adolescents, and young adults suffering from musculoskeletal disorders (MMD) who exhibit complex conditions characterized by rare and severe anomalies in skeletal development. These abnormalities may affect bones, joints, and musculotendinous structures.
Intervention: Deformity correction (Procedure)
Outcomes
Primary Outcomes
Achieved skeletal corrections
Time Frame: After 1 year
Assessment of achieved skeletal corrections compared to planned corrections, measured on standard radiographs or CT scans depending on the type of deformity corrected
Achieved skeletal corrections
Time Frame: At baseline (day 0)
Assessment of achieved skeletal corrections compared to planned corrections, measured on standard radiographs or CT scans depending on the type of deformity corrected
Secondary Outcomes
- Operating room times(At baseline (day 0))
- Blood loss(At baseline (day 0))
- Suitability of GSIs(At baseline (day 0))
- Fluoroscopy times(At baseline (day 0))
- Intra- and peri-operative complications(At baseline (day 0))
- Suitability of PSIs(At baseline (day 0))
- Suitability of bone graft(At baseline (day 0))
- Clinical-functional outcome(After 1 year)
- Clinical-functional outcome(At baseline (day 0))