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

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