Long-term follow-up of the CAD/CAM patient fitted total temporomandibular joint reconstruction system

Abstract

Purpose: The purpose of this study was the assessment of the long-term safety and effectiveness of the Techmedica (Camarillo, CA) CAD/CAM Total Temporomandibular Joint Reconstruction System (now called the TMJ Concepts Patient Fitted Total Temporomandibular Joint Reconstruction System, Ventura, CA). Patients and Methods: A survey was mailed to the available addresses of 170 (79%) of the 215 patients who had been implanted with the Techmedica System devices between 1990 and 1994. Seventy-nine (46%) surveys were returned by the US Postal Service as undeliverable. Three patients (1.4%) were reported as deceased in returns from relatives. Therefore, of the remaining 91 possible responses, 60 (65.9%) were returned. Fifty-eight (58) surveys, considered complete and valid (96.7%), representing 97 (39 bilateral, 19 unilateral) devices with a mean follow-up of 107.4 ± 15.5 months (range, 60 to 120 months) were analyzed. Subjective data related to pain, mandibular function, diet consistency, and present quality of life were collected using visual analog scales. Objective measures of mandibular interincisal opening and lateral excursions were obtained from direct measurements using the Therabite (Therabite, Philadelphia, PA) measuring scale provided in the survey with instructions as to its use. Results: Analysis of the subjective data at 10 years revealed a 76% reduction in mean pain scores and a 68% increase in mean mandibular function and diet consistency scores (P <.0001). Analysis of objective data revealed a 30% improvement in mandibular range of motion after 10 years (P =.0009). Long-term quality of life improvement scores were statistically related to the number of prior temporomandibular joint operations the patients had undergone. Conclusion: These data indicate that the CAD/CAM Patient Fitted Total Temporomandibular Joint Reconstruction System has proved to be a safe and effective long-term management modality in the patient population surveyed for this study. © 2002 American Association of Oral and Maxillofacial Surgeons J Oral Maxillofac Surg 60:1440-1448, 2002