Bioceramic implants could unleash a revolution.Ceramics that come close to mimicking bone could, if deemed safe and useful, replace a lot of metal and polymer implants.Now, a long term follow-up study indicates that patient-specific bioceramic implants could be a successful alternative for some procedures.
The performance of implants using Lithoz’s LithaBone TCP 300 tricalcium phosphate made on a CeraFab 3D printer was evaluated by a team at Division of Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge AV, in Bruges, Belgium.Aided by researchers from KLS Martin Group, the team found encouraging results.KLS Martin is a materials and surgical implant systems group based in Germany.
The family-owned company is not well known outside its area of expertise, but in CMF and beyond, KLS is renowned for products such as personalized thoracic planning tools and devices like hand implant tools, screws, and instruments.The company also regularly collaborates with cutting edge researchers and practitioners to bring new technologies to market.KLS has been 3D printing custom CMF implants for many years; we wrote about their work with 3D Systems and Concept Laser in 2017.
In 2016, KLS set up a 3D printing facility for custom CMF tools and implants in Jacksonville.The researchers, meanwhile, include notable maxillofacial and facial plastic surgeon Gwen Swennen.The long term study covers just 14 patients, who will be followed over five years.
The patients have undergone a bilateral sagittal split osteotomy (BSSO), a reconstructive procedure undertaken to regain function in the jaw and improve esthetics.For the procedure, the upper and lower jaw are separated and then reattached.This kind of an osteotomy procedure could help a person chew, speak, and breathe better but entails risks as well.
The possibility of injury and permanent disfunction are present with this procedure, and neurological, reduced mobility, nerve issues, and long term pain could result.In this case, the patients had dysgnathia, or jaw misalignment.Ideally recovery takes around two months, but a full recovery could take half a year or more.
Incorrect screw placement is one error that leads to long term issues for patients.Given the complexity and significant effects of this procedure, it is a good candidate for planning software.CMF generally has been an ideal case for personalized implants as well, with real benefits having shown their value there across three decades.
Lithoz CEO, Dr.Johannes Homa, said: ¨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 process used is what Lithoz calls LCM and we call Slurry SLA, and the implants were made of Beta-tricalcium phosphate.
In this case, patient-specific resorbable bone implants were created to fit the osteotomy gap.This is a hollow that is created when the jaws are cut and realigned.To create the implants and plan the surgery, a surgical planning software tool was used.
In the 14 patients, there were two minor long-term complications, with the rest of the procedures rated good.Results are based on a relatively small sample, but this is very encouraging overall.Resorbable bone implants could be used in many procedures across the body.
Ceramic 3D printed implants could also become much more common across the body.Tricalcium phosphate implants in particular could be a close to bone material that may be safer and offer less complications than metals or polymers.Personalized implants suffer from a lot of hype, but in this case and many others, could solve unique problems in the body with unique parts well.
Good preoperative digital planning software is a cornerstone of Materialise’s offering, with many other companies jumping into this market as well.Resorbable implants minimize the amount of procedures needed, corrective procedures, and long-term issues.The combination of a ceramic, resorbable, digitally planned, customized implant therefore is a beautiful case for additive.
Across CMF and the skeletal system more generally, other examples will be found where similar procedures and implants could play a role.This is an excellent achievement for Lithoz, KLS, and the researchers involved.It is also a major milestone for the Additive Manufacturing industry which points to many more opportunities ahead.
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