A study following 14 patients who received a 3D printed beta-TCP patient-specific implant (PSI) made from Lithoz’s TCP 300 tricalcium phosphate on a CeraFab system has shown overwhelmingly successful results. Each of the patients underwent jaw corrective surgery between July 9, 2017 and July 31, 2018 and their recovery was observed over the course of five years in a clinical study. The results of this recently published study found that there was a total grafting success rate of 92.9%.
The surgery in question was a bilateral sagittal split osteotomy (BSSO), a relatively common procedure for correcting lower jaw irregularities, such as misalignment. With the conventional procedure, however, there is a risk of antegonial notching, which can create a concavity in the face and “lead to unpleasant aesthetic outcomes”. The medical field has therefore been exploring new methods to minimize the risk of notching, including using patient-specific implants made from a biocompatible and resorbable ceramic material.
Back in 2017 and 2018, a series of patient-specific implants were 3D printed from Lithoz’s LithaBone TCP 300 tricalcium phosphate material. These implants were placed in the osteotomy gaps of 14 patients (nine female and five male). In the aftermath of these surgeries, the early results were evaluated, with medical researchers finding that the β-TCP implants were positioned without any complications.
The follow-up with the patients five years later found that there were only two minor long-term complications, and that the total grafting success rate was 92.9%. Moreover, there were no wound healing issues or infections at the surgical site. This clinical study, published in the International Journal of Oral and Maxillofacial Surgery, represents the first long-term scientific study on 3D printed bioceramic PSIs.
Dr. Johannes Homa, Lithoz CEO, said of the paper’s significance: “This first ever long-term clinical follow-up study marks an 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.”
The five-year follow-up study is a notable step for ceramic additive manufacturing in the medical sphere and in surgeries specifically. Bioceramics like tricalcium phosphate have several benefits in surgeries, since the materials are biocompatible and osteoconductive. The ability to 3D print these bioceramics means that patients can benefit from custom fit implants as well as geometries optimized for osteoconductivity, including porous implants. In the clinical study’s conclusion, the researchers show “the feasibility and potential of the ß-TCP gap PSI concept as an innovative and promising approach to prevent antegonial notching after BSSO at primary surgery and in the long term.”
Lithoz’s ceramic AM solutions and materials today have broad applications across healthcare. Last year, for instance, the company 3D printed a ceramic subperiosteal jaw implant, which was successfully implanted in a patient as part of the EU-funded INKplant project. Other applications include the large-scale production of ultra-thin ceramic insulating sleeves for a laparoscopic tool (made by BOSCH), patient specific palatal obturators for treating cleft palates, femoral stem implants for hip surgery, finger joint implants and much more.
