Biomet Microfixation Temporomandibular Joint Replacement System: A 3-Year Follow-Up Study of Patients Treated During 1995 to 2005

Purpose: To assess the safety and efficacy of a stock alloplastic total temporomandibular joint (TMJ) implant system, the Biomet Microfixation TMJ Replacement System. Materials and Methods: During a 10-year multicenter clinical trial from 1995 to 2005, 442 Biomet Microfixation TMJ Replacement Systems were implanted in 288 patients (154 bilaterally and 134 unilaterally). Patients were followed at landmark times, including the date of surgery and at 1 month, 3 months, 1 year, 1 year 6 months, and 3 years. The 3 major metrics that were evaluated were preoperative and postoperative pain, interference with eating, and maximal incisal opening. Paired t tests and comparison analyses were used to assess outcomes. Results: There was statistically significant improvement in pain level (P = .0001), jaw function (P = .0001), and incisal opening (P = .0001). Although there were complications necessitating the removal of 14 of 442 implants (3.2%), there were no device-related mechanical failures. Conclusions: The clinical study presented supports the conclusion that a stock TMJ alloplastic replacement, based on sound orthopedic and biomedical principles, is a safe and efficacious option when alloplastic reconstruction of the TMJ is indicated. c 2012 American Association of Oral and Maxillofacial Surgeons J Oral Maxillofac Surg 70:787-794, 2012