Purpose: The purpose of this study was to continue the assessment of the safety and effectiveness of the Patient-Fitted Total Temporomandibular Joint Reconstruction System (now, TMJ Concepts Patient-Fitted Total Temporomandibular Joint Reconstruction System, Ventura, CA; previously referred to as Techmedica, Camarillo, CA, the CAD/CAM Patient-Fitted Total Temporomandibular Joint Reconstruction System).
Patients and methods: Questionnaires were mailed to the available addresses of 193 patients who had been implanted with Techmedica/TMJ Concepts devices between 1990 and 2004. Of 193 recorded addresses, 149 (77.2%) were valid, and 44 (22.7%) were returned by the US Postal Service as undeliverable. Two (1%) surveys were remailed; both were returned completed. A total of 61 (31.6%) surveys were returned properly completed. This represented 102 devices (41 bilateral, 20 unilateral), with a mean follow-up of 11.4 years (standard deviation [SD] 3.0; range, 0 to 14). Subjective data related to pain, perception of mandibular function, diet consistency, and current quality of life were collected with the use of visual analog scales. Objective measures of maximum interincisal opening (MIO) were obtained from direct measurements with the Therabite Measuring Scale (Atos Medical, Milwaukee, WI), which was provided in the survey along with instructions on its use.
Results: Analysis of subjective data showed a significant reduction in pain scores and an increase in mandibular function and diet consistency scores (P < .001). Analysis of objective data showed an improvement in mandibular range of motion after 14 years (P = .02). Among all respondents, 85% reported quality of life (QOL) scores that showed improvement since baseline. Long-term quality of life improvement scores also were found to be statistically related to the number of previous temporomandibular joint operations the patient had undergone.
Conclusions: Outcome data presented show that the Patient-Fitted Total Temporomandibular Joint Reconstruction System continues to be a safe, effective, and reliable long-term management modality for the specific patient population surveyed in this study.