Comparison of titanium mesh implants with PLA-hydroxyapatite coatings for maxillofacial cancer reconstruction

Abstract

Since 2013 physics of TPU and oncologists from the TCRI with participation of the “ConMet” company (Moscow) and the “Sintel” company (Tomsk Special Economic Zone resident) have been working on the theme entitled “Development of the composite implants for reconstructive surgery of a craniofacial areas of the traumatological and oncological patients” supported with the Federal Program ”R&D, part 1.3”. The goal was to develop the maxillo-facial implants on the basis of the transformable titanium mesh with PLA & hydroxyapatite coating. According to the Contract No. 14.578.21.0031, the team of developers had to start supplying these advanced implants to the industrial partners up to 2017. This research was supported with the preliminary market researches by the ISPMS SB RAS and the TP “MF”. The stages of preliminary market researches were: 1) research of the Worldwide CMF market; 2) forecasting the BRIC CMF market up to 2020; 3) the total Russian market (epidemiology) estimation as a sum of official calculations and statistics; 4) looking for the best foreign analogue prices, comparing their and our implant properties; 5) search for the best Russian analogues; 6) the investigation of the world patent databaseEspacenet for the last years, and finding the owners and applicants of patents of CMF osteosynthesis plates on the basis of titanium coated with PLA & hydroxyapatite; 7) comparison of the domestic implants, and making conclusions. Several variants of the meshes have got the equal quality with the best foreign and Russian implants. The closest analogues were titanium, polyethylene, PEEK composite meshes suited to the patient shape by the Synthes company in 2014, and the only hybrid titanium "Grey" implant with layers of gelatin, dextran, collagen, HAP & BMP-2 was found. This implant was produced by Russian institution, and it was mentioned in the report on clinical trials by L.A. Pavlova et al., 2014 [1]. There are no manufacturers of the coated implants in Russia. The average price of the similar foreign implants varies from 12 up to 40