Customized Bone Allografts by 3D-printing

Conditions: Musculoskeletal Deformity, Musculoskeletal Diseases, Musculoskeletal Disorder

Summary

Virtual surgical planning (VSP), the simulation of bone corrections in virtual reality ("Computer Aided Surgical Simulation": CASS) and 3D printing of customized implants and devices are achieving an increasingly central role in clinical practice and orthopaedic surgery.Those technologies and processes allow an allow incredibly versatile and accurate planning and reproduction of complex bone correction or joint replacement procedures.Recent and converging evidence document how the use of these technologies is able to significantly reduce surgical times, bleeding and intra-operative complications, and the use of intra-operative fluoroscopy.Due to the collaboration between the ward of Pediatric Orthopedics and Traumatology of the Rizzoli Orthopedic Institute and the Department of Industrial Engineering (DIN) of the University of Bologna it was possible to experiment, validate and introduce simulation, planning and personalization technologies of interventions of corrective surgery of Musculoskeletal Disorders (MSDs) of the limbs in childhood and developmental age into clinical practice. (3D-MALF - CE AVEC: 356/2018/Sper/IOR).Currently, extremely complex bone correction interventions are often planned and performed through Computer Aided Design (CAD) and 3D printing of models and custom sterilizable cutting guides (Patient-Specific Instrument, PSI).In pediatric orthopedic surgery is often necessary to use homologous massive bone grafts customized on the patient's anatomy, which can be employed in the replacement of neoplastic lesions, in the axial correction of deformities or even in the extemporaneous lengthening of bone segments.The Musculoskeletal Tissue Bank (BTM) regularly provides bone grafts processed in a Class A controlled contamination environment according to GMP (Clean Room), guaranteeing quality and microbiological safety. The current realization standard of bone grafts on specific request is a freehand realization. The BTM technicians model the grafts, based on the indications received (length, width, height, indications on geometry), using standard surgical instruments (osteotomes, oscillating saws, etc.).The present clinical trial aims to validate the feasibility, accuracy and effectiveness of an innovative process for producing customized bone allografts to correct bone deformities in children. the customization process will be conducted by using computer-aided surgical simulation and 3D printing.

Eligibility Criteria

Inclusion Criteria:From 2 to 18 years oldDiagnosis of limbs musculoskeletal diseasesNeed for uni- or poly-axial correction through one or more osteotomiesNeed for massive bone graft to stabilize the correctionConsent to the processing of dataExclusion Criteria:Patients who refuse the VSP studyPatients who do not undergo in-depth radiological examinations or patients with insufficient radiological documentationPatients who undergo different interventions for the correction of musculoskeletal diseasePatients who do not need a massive bone graftPregnant women

Source: ClinicalTrials.gov (NCT05700526). StuddyBuddy aggregates publicly available trial information.