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

Not Applicable

Recruiting

• Conditions: Musculoskeletal Disorder; Musculoskeletal Deformity; Musculoskeletal Abnormalities
• Interventions: Procedure: Deformity correction

• Registration Number: NCT06380530
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-18
• Study First Submitted QC: 2024-04-23
• Study First Posted: 2024-04-24
• Study Start: 2024-10-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-13
• Primary Completion: 2028-05
• Study Completion: 2029-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pediatric patients with musculoskeletal diseases	Deformity correction	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.

Primary Outcome Measures

Name	Time	Method
Achieved skeletal corrections	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 Outcome Measures

Name	Time	Method
Blood loss	At baseline (day 0)	Blood loss for each patient
Suitability of GSIs	At baseline (day 0)	Suitability of GSIs, if needed, in relation to the planned surgery
Fluoroscopy times	At baseline (day 0)	Fluoroscopy times for each planned procedure
Intra- and peri-operative complications	At baseline (day 0)	Intra- and peri-operative complications for each patient
Suitability of PSIs	At baseline (day 0)	Suitability of PSIs in relation to the planned surgery
Suitability of bone graft	At baseline (day 0)	Suitability of bone graft, if needed, in relation to the planned surgery
Clinical-functional outcome	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
Operating room times	At baseline (day 0)	Operating room times for each planned procedure

Trial Locations

Locations (7)

IRCCS Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, BO, Italy

Istituto Clinico Humanitas; 🇮🇹 Rozzano, MI, Italy

Istituto Giannina Gaslini; 🇮🇹 Genova, Italy

Galeazzi Orthopedic Institute; 🇮🇹 Milano, Italy

Policlinico San Matteo; 🇮🇹 Pavia, Italy

Istituto Nazionale Tumori Regina Elena; 🇮🇹 Roma, Italy

Ospedale Pediatrico Bambino Gesù; 🇮🇹 Roma, Italy