Austrian ceramic 3D printing company Lithoz has achieved a 92% success rate in a clinical long-term follow-up study of its beta TCP patient-specific implants (PSI). The study confirmed that its 3D printed implants made using Lithoz’s CeraFab printer are effective bone substitutes, showing strong osteoconductive and osteoinductive properties with no post-surgical complications. The study’s findings aim to support the broader clinical adoption of ceramic 3D printing in surgical applications.
“This first ever long-term clinical follow-up study marks a historic moment for the entire additive manufacturing industry. These results are not only about celebrating a great achievement for our Lithoz LCM technology. By clinically proving a success rate of over 92%, we’ve set a game-changing milestone in the history of surgery to establish the 3D printing of patient-specific bioceramic implants as a fully-fledged alternative alongside traditional surgical interventions,” said Dr. Johannes Homa, CEO of Lithoz.
Clinical Application and Observations
The study assessed the long-term healing outcomes of ceramic implants made using LCM technology in human patients over a five-year period. It was conducted by G.R.J. Swennen, Y. Weinberg, and L. Pottel from AZ Sint-Jan Brugge, and A. Aksu and F. Reinauer from KLS Martin. Between July 9, 2017, and July 31, 2018, the study involved 14 patients aged 17 to 57 diagnosed with dysgnathia, a condition involving jaw misalignment or malformation. Nine were female (64.3%) and five were male (35.7%).
The patients received PSIs 3D printed on a Lithoz CeraFab to prevent antegonial notching, a common complication after jaw surgery. Thanks to their interconnected porous structure, the implants demonstrated strong osteoconductive and osteoinductive properties, promoting rapid bone regeneration and effectively bridging the osteotomy gap following surgical bone-cutting procedures. The study also found that the beta-TCP implants actively promoted the rapid growth of new bone tissue.
The paper highlighted that, prior to this study, no ideal solution was available for managing mandibular lower border defects and irregularities following bilateral sagittal split osteotomy (BSSO). The study concluded that this approach shows promise in addressing these irregularities and could serve as a viable long-term solution to prevent antegonial notching.
3D Printed Medical Implants
This study contributes to ongoing advancements in 3D printed medical implants. In 2023, Lithoz entered a partnership with Himed, a New York-based biomaterials company, to co-develop medical implants using biocompatible calcium phosphates (CaP). This initiative responds to growing demand for printable bioceramic feedstocks in the healthcare sector.
In early 2024, the first surgeries using a 3D printed spinal implant made from Evonik’s VESTAKEEP i4 3DF PEEK filament were performed. Developed by U.S.-based firm Curiteva, the device is the first commercially available spinal implant made from fully interconnected porous PEEK.
Separately, Dutch startup Bond3D and Invibio Biomaterials Solutions announced the development of customizable spinal cage implants. These devices are engineered to support bone regeneration and improve patient recovery outcomes in spinal surgery.
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Featured image shows Three TCP Implants. Image via Lithoz.
