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

Abstract

PurposeThe aim of this study is to present the preliminary clinical data on the OMX Temporomandibular Joint (TMJ) Prosthetic total joint replacement system. Materials and MethodsA 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. ResultsBased 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. ConclusionThis 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.