Invited review article: Patient-specific 3D-Printed metal plates for osteotomy and fracture fixation: An illustrative series with workflow and regulatory considerations

Abstract

Objectives: To report on the process and results of clinical application of 3D printed patient-specific metal plates in orthopaedic trauma. Materials and Methods: A retrospective review was conducted on 11 pilot patients managed with 3D printed Patient-Specific Plates (PSPs) together with 3D printed guides, 3D printed bone models and 3D virtual planning for malunions or acute fractures. There were six clavicles, three forearm shafts, one ankle, and one tibial plateau. The surgeon and the engineering team collaborated on the designing of customized treatment solutions for each case. Results: From obtaining the CT data to manufacture of all 3D printed parts, the required ranged from 3 to 43 days (mean 16 days) and the cost ranged from 1590 to 4100 USD (mean 1360 USD). All 11 patients were followed up from 6 to 24 months. All patients had bony union, good to excellent clinical outcomes documented from clinical scores and with no complications. Challenges with the workflow were collected qualitatively and listed out. Conclusion: Implementation of 3D printing technology with customized patient specific implants appears to be beneficial with good outcomes in patients with complex anatomy and malunions. We have described the logistical and regulatory considerations. Further studies should be conducted to demonstrate its cost-effectiveness compared to conventional solutions.