Deformity correction
ProcedureSurgeries to correct bone defomity, supported by the use of preoperative planning and/or patient-specific instruments
NCT Number: NCT06380530
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.
Interested in participating?
Request Info2 year–40 year
All sexes
Interventional
Not applicable
IRCCS Istituto Ortopedico Rizzoli, Bologna, BO, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Surgeries to correct bone defomity, supported by the use of preoperative planning and/or patient-specific instruments
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
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
Time frame: At baseline (day 0)
Operating room times for each planned procedure
Time frame: At baseline (day 0)
Fluoroscopy times for each planned procedure
Time frame: At baseline (day 0)
Blood loss for each patient
Time frame: At baseline (day 0)
Intra- and peri-operative complications for each patient
Time frame: At baseline (day 0)
Suitability of PSIs in relation to the planned surgery
Time frame: At baseline (day 0)
Suitability of GSIs, if needed, in relation to the planned surgery
Time frame: At baseline (day 0)
Suitability of bone graft, if needed, in relation to the planned surgery
Time frame: At baseline (day 0)
Clinical-functional outcome will be assessed by preoperative and one-year follow-up administration of the Pediatric Outcome Data Collection Instrument (PODCI) questionnaire for pediatric patients or the Short Form Health Survey 36 (SF-36) for young adults
Time frame: After 1 year
Clinical-functional outcome will be assessed by preoperative and one-year follow-up administration of the Pediatric Outcome Data Collection Instrument (PODCI) questionnaire for pediatric patients or the Short Form Health Survey 36 (SF-36) for young adults
Time frame: At baseline (day 0)
The cost analysis will entail evaluating expenses associated with various components, including imaging required for planning, production of 3D-printed instrumentation such as PSIs and GSIs, and bone grafts. Additionally, human costs for planning will be considered. Surgical-related costs will be assessed by comparing them with those of traditional surgeries to gauge the cost-effectiveness of the procedure, taking into account the achieved correction and the necessity for additional procedures.
Contact information is provided by the study sponsor or research team.
Istituto Ortopedico Rizzoli
Other
Acronym: SIMULA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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