A new three-dimensional, print-on-demand temporomandibular prosthetic total joint replacement system: Preliminary outcomes.

PURPOSE: The aim of this study is to present the preliminary clinical data on the OMX Temporomandibular Joint (TMJ) Prosthetic total joint replacement system.

MATERIALS AND

METHODS

A prospective, cohort, clinical study was undertaken of consecutive adult patients with Category 5 end-stage joint disease who were implanted with the OMX TMJ prosthesis between May 2015 and April 2017. A total of 50 devices were implanted in 38 patients, with 12 patients receiving bilateral prosthetic joints. There were 31 females and 7 males in this cohort, who ranged in age from 20 to 66 years, with a mean of 43.8 years (±14.0 years). Ten of the 50 prosthetic joints (20%) were fully customized, while the remaining were patient matched using virtual planning software.

RESULTS

Based on a mean follow-up period of 15.3 months (range 12-24 months) following the TMJ total joint replacement, preliminary results suggest the OMX TMJ prosthesis has made a positive impact on clinical outcomes, with a mean 74.4% reduction in joint pain levels and significant improvements (p < 0.05) in jaw function as measured by the visual analogue scales for mouth opening (30.8%), diet (77.1%), and function (59.2%). No device failures were reported during the study period.

CONCLUSION

This study suggests that the print-on-demand OMX TMJ prosthesis, designed for rapid delivery of both patient-matched and fully customize devices, represents a safe, reliable and versatile implantable joint replacement system for the treatment of category 5 end-stage TMJ disease.