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RecruitingNCT06380530SIMULAUpdated Dec 26, 2025

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

An interventional study of Deformity correction in Musculoskeletal Deformity, Musculoskeletal Abnormalities and Musculoskeletal Disorder, sponsored by Istituto Ortopedico Rizzoli. Recruiting at 7 sites in Italy. Open to participants aged 2 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-12-26.

Sponsored by Istituto Ortopedico Rizzoli · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2024; still recruiting 1 year 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
2 Years to 40 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Musculoskeletal Deformity
  • Musculoskeletal Abnormalities
  • Musculoskeletal Disorder

Keywords

  • Virtual Surgical Planning
  • Patient-Specific instrument
  • Graft-Specific instrument
  • Pediatric Orthopedics
03

In context

Musculoskeletal Diseases

657 studies on the registry are indexed under Musculoskeletal Diseases; 159 are open to participants now.

This study's planned enrollment of 100 is above the median of 73 across 438 interventional studies indexed under Musculoskeletal Diseases.

Browse Musculoskeletal Diseases studies →

Lead sponsor

Istituto Ortopedico Rizzoli is the lead sponsor of 298 studies on the registry; 102 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 40 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    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.

    Procedure: Deformity correction

Interventions

  • ProcedureDeformity correction

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

06

What researchers measure

Primary outcomes

  1. Achieved skeletal corrections

    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)

  2. Achieved skeletal corrections

    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

Secondary outcomes

  1. Operating room times

    Operating room times for each planned procedure

    Time frame: At baseline (day 0)

  2. Fluoroscopy times

    Fluoroscopy times for each planned procedure

    Time frame: At baseline (day 0)

  3. Blood loss

    Blood loss for each patient

    Time frame: At baseline (day 0)

  4. Intra- and peri-operative complications

    Intra- and peri-operative complications for each patient

    Time frame: At baseline (day 0)

  5. Suitability of PSIs

    Suitability of PSIs in relation to the planned surgery

    Time frame: At baseline (day 0)

  6. Suitability of GSIs

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

    Time frame: At baseline (day 0)

  7. Suitability of bone graft

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

    Time frame: At baseline (day 0)

  8. Clinical-functional outcome

    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)

  9. Clinical-functional outcome

    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

Other outcomes

  1. Cost analysis

    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.

    Time frame: At baseline (day 0)

07

Study locations

1 of 7 sites recruiting
  • IRCCS Istituto Ortopedico Rizzoli
    Bologna, BO 40136, Italy
    Recruiting
  • Istituto Clinico Humanitas
    Rozzano, MI, Italy
    Not yet recruiting
  • Istituto Giannina Gaslini
    Genova, Italy
    Not yet recruiting
  • Galeazzi Orthopedic Institute
    Milan, Italy
    Not yet recruiting
  • Policlinico San Matteo
    Pavia, Italy
    • Gianluigi Pasta, MD · Contact
    Not yet recruiting
  • Istituto Nazionale Tumori Regina Elena
    Roma, Italy
    Not yet recruiting
  • Ospedale Pediatrico Bambino Gesù
    Roma, Italy
    Not yet recruiting
08

References and documents

Publications

  • R. Michaels et al., "3D printing in surgical simulation: emphasized importance in the COVID-19 pandemic era," https://doi.org/10.2217/3dp-2021-0009, vol. 5, no. 1, pp. 5-9, May 2021, doi: 10.2217/3DP-2021-0009.
  • S. Dash, S. K. Shakyawar, M. Sharma, and S. Kaushik, "Big data in healthcare: management, analysis and future prospects," J Big Data, vol. 6, no. 1, pp. 1-25, Dec. 2019, doi: 10.1186/S40537-019-0217-0/FIGURES/6.
  • G. Pravettoni and S. Triberti, "A 'P5' Approach to Healthcare and Health Technology," P5 eHealth: An Agenda for the Health Technologies of the Future, pp. 3-17, 2020, doi: 10.1007/978-3-030-27994-3_1.
  • Anaya JM, Duarte-Rey C, Sarmiento-Monroy JC, Bardey D, Castiblanco J, Rojas-Villarraga A. Personalized medicine. Closing the gap between knowledge and clinical practice. Autoimmun Rev. 2016 Aug;15(8):833-42. doi: 10.1016/j.autrev.2016.06.005. Epub 2016 Jun 11. PubMed 27302209 ↗
  • Coppola L, Cianflone A, Grimaldi AM, Incoronato M, Bevilacqua P, Messina F, Baselice S, Soricelli A, Mirabelli P, Salvatore M. Biobanking in health care: evolution and future directions. J Transl Med. 2019 May 22;17(1):172. doi: 10.1186/s12967-019-1922-3. PubMed 31118074 ↗
  • Pop B, Fetica B, Blaga ML, Trifa AP, Achimas-Cadariu P, Vlad CI, Achimas-Cadariu A. The role of medical registries, potential applications and limitations. Med Pharm Rep. 2019 Jan;92(1):7-14. doi: 10.15386/cjmed-1015. Epub 2019 Jan 15. PubMed 30957080 ↗
  • Dorsey ER. The new platforms of health care. NPJ Digit Med. 2021 Jul 15;4(1):112. doi: 10.1038/s41746-021-00478-5. PubMed 34267312 ↗
  • Tumiene B, Graessner H, Mathijssen IM, Pereira AM, Schaefer F, Scarpa M, Blay JY, Dollfus H, Hoogerbrugge N. European Reference Networks: challenges and opportunities. J Community Genet. 2021 Apr;12(2):217-229. doi: 10.1007/s12687-021-00521-8. Epub 2021 Mar 17. PubMed 33733400 ↗
  • Vivarelli L, Govoni M, Attala D, Zoccali C, Biagini R, Dallari D. Custom Massive Allograft in a Case of Pelvic Bone Tumour: Simulation of Processing with Computerised Numerical Control vs. Robotic Machining. J Clin Med. 2022 May 15;11(10):2781. doi: 10.3390/jcm11102781. PubMed 35628908 ↗
  • Benedetti MG, et al. Prot. CHILD-DEROT. 'Studio pilota per la pianificazione del trattamento alterazioni torsionali dell'arto inferiore nei bambini affetti da paralisi cerebrale infantile mediante valutazione integrata morfologica e funzionale.' CE AVEC 718/2021/Oss/IOR. 30/09/2021.
  • L. Frizziero et al., "Computer-aided surgical simulation for correcting complex limb deformities in children," Applied Sciences (Switzerland), vol. 10, no. 15, Aug. 2020, doi: 10.3390/app10155181.
  • Raza M, Murphy D, Gelfer Y. The effect of three-dimensional (3D) printing on quantitative and qualitative outcomes in paediatric orthopaedic osteotomies: a systematic review. EFORT Open Rev. 2021 Feb 1;6(2):130-138. doi: 10.1302/2058-5241.6.200092. eCollection 2021 Feb. PubMed 33828856 ↗
  • Grassi FR, Grassi R, Vivarelli L, Dallari D, Govoni M, Nardi GM, Kalemaj Z, Ballini A. Design Techniques to Optimize the Scaffold Performance: Freeze-dried Bone Custom-made Allografts for Maxillary Alveolar Horizontal Ridge Augmentation. Materials (Basel). 2020 Mar 19;13(6):1393. doi: 10.3390/ma13061393. PubMed 32204393 ↗
  • Frizziero L, Santi GM, Leon-Cardenas C, Donnici G, Liverani A, Papaleo P, Napolitano F, Pagliari C, Di Gennaro GL, Stallone S, Stilli S, Trisolino G, Zarantonello P. In-House, Fast FDM Prototyping of a Custom Cutting Guide for a Lower-Risk Pediatric Femoral Osteotomy. Bioengineering (Basel). 2021 May 26;8(6):71. doi: 10.3390/bioengineering8060071. PubMed 34073324 ↗
  • L. Frizziero et al., "Paediatric orthopaedic surgery with 3D printing: Improvements and cost reduction," Symmetry (Basel), vol. 11, no. 10, Oct. 2019, doi: 10.3390/sym11101317.
  • L. Frizziero et al., "An innovative and cost-advantage cad solution for cubitus varus surgical planning in children," Applied Sciences (Switzerland), vol. 11, no. 9, May 2021, doi: 10.3390/app11094057.
  • "3D-MALF: 'Modelli 3D-printing nel planning preoperatorio del paziente pediatrico affetto da malformazioni congenite. Studio pilota.' - CE AVEC: 356/2018/Sper/IOR".
  • "3D-MALF II: 'Innesti ossei personalizzati mediante analisi tridimensionale nelle deformità scheletriche in età pediatrica' - CE AVEC: 301/2022/Sper/IOR."
  • L. Frizziero et al., "New Methodology for Diagnosis of Orthopedic Diseases through Additive Manufacturing Models," Symmetry 2019, Vol. 11, Page 542, vol. 11, no. 4, p. 542, Apr. 2019, doi: 10.3390/SYM11040542.
  • L. Frizziero et al., "Effectiveness assessment of CAD simulation in complex orthopedic surgery practices," Symmetry (Basel), vol. 13, no. 5, May 2021, doi: 10.3390/sym13050850.
  • F. Osti et al., "CT conversion workflow for intraoperative usage of bony models: From DICOM data to 3D printed models," Applied Sciences (Switzerland), vol. 9, no. 4, Feb. 2019, doi: 10.3390/app9040708.
  • G. Durastanti, C. Belvedere, M. Ruggeri, D. M. Donati, B. Spazzoli, and A. Leardini, "A Pelvic Reconstruction Procedure for Custom-Made Prosthesis Design of Bone Tumor Surgical Treatments," Applied Sciences 2022, Vol. 12, Page 1654, vol. 12, no. 3, p. 1654, Feb. 2022, doi: 10.3390/APP12031654.
  • Alessandri G, Frizziero L, Santi GM, Liverani A, Dallari D, Vivarelli L, Di Gennaro GL, Antonioli D, Menozzi GC, Depaoli A, Rocca G, Trisolino G. Virtual Surgical Planning, 3D-Printing and Customized Bone Allograft for Acute Correction of Severe Genu Varum in Children. J Pers Med. 2022 Dec 12;12(12):2051. doi: 10.3390/jpm12122051. PubMed 36556271 ↗
  • Archunan MW, Petronis S. Bone Grafts in Trauma and Orthopaedics. Cureus. 2021 Sep 4;13(9):e17705. doi: 10.7759/cureus.17705. eCollection 2021 Sep. PubMed 34650879 ↗
  • Depaoli A, Menozzi GC, Di Gennaro GL, Ramella M, Alessandri G, Frizziero L, Liverani A, Martinelli D, Rocca G, Trisolino G. The Flipping-Wedge Osteotomy: How 3D Virtual Surgical Planning (VSP) Suggested a Simple and Promising Type of Osteotomy in Pediatric Post-Traumatic Forearm Deformity. J Pers Med. 2023 Mar 19;13(3):549. doi: 10.3390/jpm13030549. PubMed 36983730 ↗
  • Customized Bone Allografts by 3D-printing - Full Text View - ClinicalTrials.gov." https://classic.clinicaltrials.gov/ct2/show/NCT05700526?term=malf&cntry=IT&draw=2&rank=1 (accessed Aug. 21, 2023)
  • Frizziero L, Santi GM, Leon-Cardenas C, Ferretti P, Sali M, Gianese F, Crescentini N, Donnici G, Liverani A, Trisolino G, Zarantonello P, Stallone S, Di Gennaro GL. Heat Sterilization Effects on Polymeric, FDM-Optimized Orthopedic Cutting Guide for Surgical Procedures. J Funct Biomater. 2021 Nov 19;12(4):63. doi: 10.3390/jfb12040063. PubMed 34842761 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06380530
Lead sponsor
Istituto Ortopedico Rizzoli
Collaborators
Ospedale Pediatrico Bambino Gesù, Istituto Giannina Gaslini, Galeazzi Orthopedic Institute, Istituto Nazionale Tumori Regina Elena, Policlinico San Matteo, Istituto Clinico Humanitas
Responsible party
Sponsor
First posted
Apr 24, 2024
Start date
Oct 31, 2024
Primary completion
May 2028 (estimated)
Completion
May 2029 (estimated)
Last update
Dec 26, 2025

Study contacts

Grazia Chiara Menozzi
Contact
graziachiara.menozzi@ior.it
0516366 ext. 484
Giovanni Trisolino, MD
Contact
giovanni.trisolino@ior.it
0516366 ext. 484
Pierfrancesco Costici, MD
principal investigator · Ospedale Pediatrico Bambin Gesù
Giorgio Marrè Brunenghi, MD
principal investigator · Istituto Giannina Gaslini
Fabio Verdoni, MD
principal investigator · Galeazzi Orthopedic Institute
Roberto Biagini, MD
principal investigator · Istituto Nazionale Tumori Regina Elena
Gianluigi Pasta, MD
principal investigator · Policlinico San Matteo
Tommaso Bonanzinga, MD
principal investigator · Istituto Clinico Humanitas

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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