Post-Approval Study (PMA CoA) in Order to Obtain Additional Long Term Safety and Effectiveness Data \[PMA P020016\]
An additional three-year follow-up data will be collected on subjects previously enrolled in the PMA study, who had not completed follow-up prior to the PMA approval \[PMA P020016\].
Study Type
OBSERVATIONAL
Enrollment
93
Total replacement of the temporomandibular joint with a Biomet TMJ Replacement System
Riley Hospital
Indianapolis, Indiana, United States
Jeffrey S. Topf, D.D.S.
West Bloomfield, Michigan, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
The University of Texas,Southwestern Medical School
Dallas, Texas, United States
Time to Revision
Time from surgical alloplastic reconstruction of the TMJ to revision surgery (Re-operation or removal)
Time frame: 3 years
jaw pain intensity (VAS score)
Pain level is recored in a 10 cm line according the intensity of pain, where zero on the far left represents "no pain" and 10 on the far right, represent the maximum level of pain experienced
Time frame: 1 year, 1.5 years
Interference with eating
Interference of eating is recored in a 10 cm line according the intensity of the interference with eating, where zero on the far left represents "no interference with eating" and 10 on the far right, represent the maximum level of interference with eating experienced
Time frame: 1 year, 1.5 years
Maximun Incisal Opening
Maximum Incisal Opening (MIO) is the distance measured in millimeters (mm) from the incisal edge of the maxillary central incisors to the incisal edge of the mandibular central incisors at the midline with the mouth wide open.
Time frame: 1 year, 1.5 years
Patient Satisfaction
Patient satisfaction is the level of comfort with the TMJ reconstruction that a given patient experiences. It is expressed as "very satisfied", "satisfied", "dissatisfied" or "failure"
Time frame: 6 months, 1 year, 1.5 years, and 3 years
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