Advanced Surgical Simulation Processes in the Correction of Skeletal Defects and Deformities
Musculoskeletal Deformity · Musculoskeletal Abnormalities · Musculoskeletal Disorder
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 2 años - 40 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 100 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
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
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- No aplica
- Enmascaramiento
- Sin enmascaramiento
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
Deformity correction PROCEDURE
Surgeries to correct bone defomity, supported by the use of preoperative planning and/or patient-specific instruments
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Achieved skeletal corrections
Plazo: 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
Plazo: 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
Medidas secundarias
Operating room times
Plazo: At baseline (day 0)
Operating room times for each planned procedure
Fluoroscopy times
Plazo: At baseline (day 0)
Fluoroscopy times for each planned procedure
Blood loss
Plazo: At baseline (day 0)
Blood loss for each patient
Intra- and peri-operative complications
Plazo: At baseline (day 0)
Intra- and peri-operative complications for each patient
Suitability of PSIs
Plazo: At baseline (day 0)
Suitability of PSIs in relation to the planned surgery
Suitability of GSIs
Plazo: At baseline (day 0)
Suitability of GSIs, if needed, in relation to the planned surgery
Suitability of bone graft
Plazo: At baseline (day 0)
Suitability of bone graft, if needed, in relation to the planned surgery
Clinical-functional outcome
Plazo: 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
Clinical-functional outcome
Plazo: 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
Otras medidas
Cost analysis
Plazo: 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.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (7)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
7 centros
IRCCS Istituto Ortopedico RizzoliBologna, BO, ItalyReclutando
Istituto Clinico HumanitasRozzano, MI, ItalyAún no recluta
Istituto Giannina GasliniGenova, ItalyAún no recluta
Galeazzi Orthopedic InstituteMilan, ItalyAún no recluta
Policlinico San MatteoPavia, ItalyAún no recluta
Istituto Nazionale Tumori Regina ElenaRoma, ItalyAún no recluta
Ospedale Pediatrico Bambino GesùRoma, ItalyAún no recluta
Equipo y fechas
- Patrocinador principal
- Istituto Ortopedico Rizzoli
- Inicio del estudio
- 31 oct 2024 Real
- Finalización primaria
- 2028-05 Estimado
- Finalización del estudio
- 2029-05 Estimado
- Primera publicación
- 24 abr 2024 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
Advanced Surgical Simulation Processes in the Correction of Skeletal Defects and Deformities
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026