title: Biomet Microfixation Temporomandibular Joint Replacement System: a 3-year follow-up study of patients treated during 1995 to 2005.
abstract: OBJECTIVE
  To assess the safety and efficacy of a stock alloplastic total temporomandibular joint (TMJ) implant system, the Biomet Microfixation TMJ Replacement System.
  
  
  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.
authors.affiliation: Department of Oral and Maxillofacial Surgery, University of Pennsylvania, Philadelphia, PA, USA. helen.giannakopoulos@uphs.upenn.edu
authors.forename: Helen E
authors.initials: HE
authors.lastname: Giannakopoulos
authors.forename: Douglas P
authors.initials: DP
authors.lastname: Sinn
authors.forename: Peter D
authors.initials: PD
authors.lastname: Quinn
mesh_terms: D000328:Adult; D000844:Ankylosis / Q000601:surgery; D001168:Arthritis / Q000601:surgery; D019643:Arthroplasty, Replacement; D001672:Biocompatible Materials; D001862:Bone Resorption / Q000601:surgery; D016025:Bone Transplantation / Q000009:adverse effects; D020878:Device Removal; D004435:Eating / Q000502:physiology; D005157:Facial Pain / Q000145:classification; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007595:Joint Prosthesis / Q000592:standards*; D008297:Male; D010003:Osteoarthritis / Q000601:surgery; D010027:Osteotomy / Q000379:methods; D010147:Pain Measurement; D010149:Postoperative Pain / Q000145:classification; D017060:Patient Satisfaction; D011474:Prosthesis Design / Q000592:standards*; D016059:Range of Motion, Articular / Q000502:physiology; D012008:Recurrence; D012449:Safety; D013704:Temporomandibular Joint / Q000601:surgery*; D013705:Temporomandibular Joint Disorders / Q000601:surgery; D014182:Transplantation, Autologous / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D001672:Biocompatible Materials