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NCT Number: NCT06380530

Advanced Surgical Simulation Processes in the Correction of Skeletal Defects and Deformities

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.

Recruiting

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Key information

Age range

2 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Istituto Ortopedico Rizzoli, Bologna, BO, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deformity correction

Procedure

Surgeries to correct bone defomity, supported by the use of preoperative planning and/or patient-specific instruments

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Operating room times

    Time frame: At baseline (day 0)

    Operating room times for each planned procedure

  2. Fluoroscopy times

    Time frame: At baseline (day 0)

    Fluoroscopy times for each planned procedure

  3. Blood loss

    Time frame: At baseline (day 0)

    Blood loss for each patient

  4. Intra- and peri-operative complications

    Time frame: At baseline (day 0)

    Intra- and peri-operative complications for each patient

  5. Suitability of PSIs

    Time frame: At baseline (day 0)

    Suitability of PSIs in relation to the planned surgery

  6. Suitability of GSIs

    Time frame: At baseline (day 0)

    Suitability of GSIs, if needed, in relation to the planned surgery

  7. Suitability of bone graft

    Time frame: At baseline (day 0)

    Suitability of bone graft, if needed, in relation to the planned surgery

  8. Clinical-functional outcome

    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

  9. Clinical-functional outcome

    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

Other outcomes

  1. Cost analysis

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Giovanni Trisolino, MD

CONTACT

[email protected]

0516366 ext. 484

Grazia Chiara Menozzi

CONTACT

[email protected]

0516366 ext. 484

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Collaborators

  • Galeazzi Orthopedic Institute
  • Istituto Clinico Humanitas
  • Istituto Giannina Gaslini
  • Istituto Nazionale Tumori Regina Elena
  • Ospedale Pediatrico Bambino Gesù
  • Policlinico San Matteo

Registry information

Acronym: SIMULA

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Apr 24, 2024
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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