Symptoms and General Pathology

All Conditions

Musculoskeletal Diseases

Diseases and Abnormalities at or Before Birth

Wounds and Injuries

Necrosis

Arthritis

Congenital Abnormalities

Fractures, Bone

Ankylosis

Gastrointestinal Agents

All Drugs and Chemicals

Cimetidine

Antacids

Anti-Ulcer Agents

Histamine

Histamine H2 Antagonists

Histamine phosphate

Histamine Antagonists

Neurotransmitter Agents

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Cytochrome P-450 Enzyme Inhibitors

All patients required total reconstruction of the temporomandibular joint (unilateral or billateral)

Total replacement of the temporomandibular joint with a Biomet TMJ Replacement System

Biomet TMJ Replacement System

Oscar A Gonzalez, MD, DNP

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 \[PMA P020016\].

Total Temporomandibular Joint Replacement System Post Approval Study

Survivibility of the Total Temporomandibular Joint Replacement System

Time from surgical alloplastic reconstruction of the TMJ to revision surgery (Re-operation or removal)

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

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

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.

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"

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Total Temporomandibular Joint Replacement System Post Approval Study	NCT00762944	Arthroplasty	Biomet TMJ Repl...	-	Zimmer Biomet
Total Temporomandibular Joint Replacement System Post Approval Study	NCT00762944	Arthroplasty	Biomet TMJ Repl...	-	Zimmer Biomet

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