Customized Bone Allografts by 3D-printing

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.

Conditions

• Musculoskeletal Deformity
• Musculoskeletal Diseases
• Musculoskeletal Disorder

Interventions

DEVICE

Planning of multiplanar and/or multifocal osteotomies in children by using VSP, PSIs and customized structural bone allograft

Preoperative VSP is performed starting from 3D digital models obtained from DICOM data of CT-scan with a segmentation process. If applicable, a model of the contralateral limb is obtained and used as reference for the correction. The surgeon and the engineer together define the surgical strategy, establishing the correction, the design of Patient-Specific Instruments (PSIs) and the hardware to implant. Then, through VSP, an ideal model of the bone graft is designed.

DEVICE

Routine preparation of bone graft according to standard protocols

The size dimensions obtained through VSP are used by the tissue bank to manually cut a structural bone graft according to the standard protocols.

DEVICE

Preparation of bone graft with virtual bone-matching and GSIs

The best donor bone is identified by matching the 3D models provided by bone bank with the planned graft, considering not only the size but also the most suitable configuration of cortical and medullary bone. Then GSIs are designed and 3D printed to perform the exact cut on the donor bone according to the experimental protocol.

PROCEDURE

Corrective osteotomy

The acute surgical correction is performed according to VSP using PSI and the customized bone graft. Preoperative variables (age, sex, disease, deformity), intraoperative variables (operation time, intraoperative complications, use of fluoroscopy, intraoperative bleeding) are registered.

Sponsors & Collaborators

• University of Bologna

  collaborator OTHER

• Istituto Ortopedico Rizzoli

  lead OTHER

Principal Investigators

• Giovanni Trisolino, MD · IRCCS - Istituto Ortopedico Rizzoli

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

2 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-01

Primary Completion

2026-06-30

Completion

2027-06-30

Countries

• Italy

Study Locations