Customized Bone Allografts by 3D-printing

NAEnrolling by invitationINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

June 1, 2022

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2027

Conditions
Musculoskeletal DeformityMusculoskeletal DiseasesMusculoskeletal 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.

Trial Locations (1)

40136

IRCCS - Istituto Ortopedico Rizzoli, Bologna

All Listed Sponsors
collaborator

University of Bologna

OTHER

lead

Istituto Ortopedico Rizzoli

OTHER