Musculoskeletal DeformitySIMULANCT06380530
Advanced Surgical Simulation Processes in the Correction of Skeletal Defects and Deformities
A study testing Deformity correction in people with Musculoskeletal Deformity and Musculoskeletal Abnormalities, run by Istituto Ortopedico Rizzoli at 7 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 40 years
- Conditions the study is for
- Musculoskeletal Deformity, Musculoskeletal Abnormalities, Musculoskeletal Disorder
- What is being tested?
- Deformity correction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 7 sitesItaly
- Study dates
- 31 Oct 2024to May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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;
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Italy7 sites, 7 recruiting
- Recruiting
IRCCS Istituto Ortopedico Rizzoli
Bologna, BO, 40136
Grazia Chiara Menozzi, 0516266 ext. 484, graziachiara.menozzi@ior.it
- Not yet recruiting
Istituto Giannina Gaslini
Genova
Giorgio Marrè Brunenghi, MD, giorgiomarre@gaslini.org
- Not yet recruiting
Galeazzi Orthopedic Institute
Milan
Fabio Verdoni, MD, fabio.verdoni@grupposandonato.it
- Not yet recruiting
Policlinico San Matteo
Pavia
Gianluigi Pasta, MD
- Not yet recruiting
Istituto Nazionale Tumori Regina Elena
Roma
Roberto Biagini, MD, roberto.biagini@ifo.it
- Not yet recruiting
Ospedale Pediatrico Bambino Gesù
Roma
Pier Francesco Costici, MD, pierfrancesco.costici@opbg.net
- Not yet recruiting
Istituto Clinico Humanitas
Rozzano, MI
Tommaso Bonanzinga, MD, tommaso.bonanzinga@hunimed.eu
About this study
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.
Read more
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.
- Being tested
- Deformity correction
- Keywords
- Virtual Surgical Planning, Patient-Specific instrument, Graft-Specific instrument, Pediatric Orthopedics
- Medical subject headings
- Musculoskeletal Abnormalities, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deformity correctionProcedure or surgery
Surgeries to correct bone defomity, supported by the use of preoperative planning and/or patient-specific instruments
| Study group | Role | What they receive |
|---|---|---|
| Pediatric patients with musculoskeletal diseases | Experimental | 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. Receives: Procedure: Deformity correction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At baseline (day 0)
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
Measured: After 1 year
Secondary outcomes (9)
Operating room times
Operating room times for each planned procedure
Measured: At baseline (day 0)
Fluoroscopy times
Fluoroscopy times for each planned procedure
Measured: At baseline (day 0)
Blood loss
Blood loss for each patient
Measured: At baseline (day 0)
Intra- and peri-operative complications
Intra- and peri-operative complications for each patient
Measured: At baseline (day 0)
Suitability of PSIs
Suitability of PSIs in relation to the planned surgery
Measured: At baseline (day 0)
Suitability of GSIs
Suitability of GSIs, if needed, in relation to the planned surgery
Measured: At baseline (day 0)
Suitability of bone graft
Suitability of bone graft, if needed, in relation to the planned surgery
Measured: At baseline (day 0)
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
Measured: At baseline (day 0)
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
Measured: After 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start31 Oct 2024
- Primary completionMay 2028 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal DeformityStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- 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
- Investigators
- Pierfrancesco Costici, MD, Principal investigator, Ospedale Pediatrico Bambin GesùGiorgio Marrè Brunenghi, MD, Principal investigator, Istituto Giannina GasliniFabio Verdoni, MD, Principal investigator, Galeazzi Orthopedic InstituteRoberto Biagini, MD, Principal investigator, Istituto Nazionale Tumori Regina ElenaGianluigi Pasta, MD, Principal investigator, Policlinico San MatteoTommaso Bonanzinga, MD, Principal investigator, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06380530
- Sponsor's protocol ID
- SIMULA
- Acronym
- SIMULA
- Status last verified
- Dec 2025
- First submitted
- 18 Apr 2024
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 27302209Coppola 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 31118074Pop 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 30957080Dorsey ER. The new platforms of health care. NPJ Digit Med. 2021 Jul 15;4(1):112. doi: 10.1038/s41746-021-00478-5.
PubMed 34267312Tumiene 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 33733400Vivarelli 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 35628908Benedetti 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 33828856Grassi 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 32204393Frizziero 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 34073324L. 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Surgical Simulation Processes in the Correction of Skeletal Defects and Deformities
- ClinicalTrials.gov ID
- NCT06380530
- Acronym / sponsor ID
- SIMULA / SIMULA
- Keywords
- Virtual Surgical Planning, Patient-Specific instrument, Graft-Specific instrument, Pediatric Orthopedics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Collaborators
- Ospedale Pediatrico Bambino Gesù, Istituto Giannina Gaslini, Galeazzi Orthopedic Institute, Istituto Nazionale Tumori Regina Elena, Policlinico San Matteo, Istituto Clinico Humanitas
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients with musculoskeletal diseases | Experimental | Procedure: Deformity correctionChildren, 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. |
Who may qualify
- Ages
- 2 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deformity correctionSurgeries to correct bone defomity, supported by the use of preoperative planning and/or patient-specific instruments | Procedure or surgery | Pediatric patients with musculoskeletal diseases |
Primary outcome
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
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
9 secondary outcomes
Operating room times
Time frame: At baseline (day 0)
Fluoroscopy times
Time frame: At baseline (day 0)
Blood loss
Time frame: At baseline (day 0)
Intra- and peri-operative complications
Time frame: At baseline (day 0)
Suitability of PSIs
Time frame: At baseline (day 0)
Suitability of GSIs
Time frame: At baseline (day 0)
Suitability of bone graft
Time frame: At baseline (day 0)
Clinical-functional outcome
Time frame: At baseline (day 0)
Clinical-functional outcome
Time frame: After 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- BackgroundR. 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.
- BackgroundS. 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.
- BackgroundG. 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.
- Background: PubMed 27302209Anaya 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.
- Background: PubMed 31118074Coppola 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.
- Background: PubMed 30957080Pop 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.
- Background: PubMed 34267312Dorsey ER. The new platforms of health care. NPJ Digit Med. 2021 Jul 15;4(1):112. doi: 10.1038/s41746-021-00478-5.
- Background: PubMed 33733400Tumiene 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.
- Background: PubMed 35628908Vivarelli 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.
- BackgroundBenedetti 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.
- BackgroundL. 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.
- Background: PubMed 33828856Raza 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.
- Customized Bone Allografts by 3D-printing (3D-MALF 2 protocol)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deformity correction in people with Musculoskeletal Deformity and Musculoskeletal Abnormalities, run by Istituto Ortopedico Rizzoli at 7 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Grazia Chiara Menozzi (0516366 ext. 484, graziachiara.menozzi@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achieved skeletal corrections (time frame: At baseline (day 0)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06380530, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.