Unbound MEDLINE

Biomet Microfixation Temporomandibular Joint Replacement System: a 3-year follow-up study of patients treated during 1995 to 2005.

Abstract

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.

Links

  • Publisher Full Text

    • Authors

    Giannakopoulos HE, Sinn DP, Quinn PD

    Institution

    Department of Oral and Maxillofacial Surgery, University of Pennsylvania, Philadelphia, PA, USA. helen.giannakopoulos@uphs.upenn.edu

    Source

    Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons 70:4 2012 Apr pg 787-94; discussion 795-6

    MeSH

    Adult
    Ankylosis
    Arthritis
    Arthroplasty, Replacement
    Biocompatible Materials
    Bone Resorption
    Bone Transplantation
    Device Removal
    Eating
    Facial Pain
    Female
    Follow-Up Studies
    Humans
    Joint Prosthesis
    Male
    Osteoarthritis
    Osteotomy
    Pain Measurement
    Pain, Postoperative
    Patient Satisfaction
    Prosthesis Design
    Range of Motion, Articular
    Recurrence
    Safety
    Temporomandibular Joint
    Temporomandibular Joint Disorders
    Transplantation, Autologous
    Treatment Outcome

    Pub Type(s)

    Clinical Trial
    Journal Article
    Multicenter Study

    Language

    eng

    PubMed ID

    22449430