Total Temporomandibular Joint Replacement System Post Approval Study

Study Overview
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Brief Summary
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Post-Approval Study (PMA CoA) in Order to Obtain Additional Long Term Safety and Effectiveness Data [PMA P020016]

Detailed Description
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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].

Official Title
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Survivibility of the Total Temporomandibular Joint Replacement System

Conditions
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Arthroplasty

Intervention / Treatment
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* Device: Biomet TMJ Replacement System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients requiring total joint reconstruction due to: Arthritis (osteoarthritis, rheumatoid, traumatic) malignancy Ankylosis functional deformity Avascular necrosis revisions Benign neoplasms fracture Multiple operated joints Patients who are skeletally mature. Patients must have at least one of the following criteria for surgical TMJ treatment. Presence of considerable pain and/or limited function in the joint area. Clinical and imaging evidence consistent with anatomic joint pathology Previous failure of non-surgical treatment/therapy or a failed implant. High probability of patient improvement by surgical treatment. Patients must be able to return for follow-up examinations. Patients without serious compromising general medical conditions. Exclusion Criteria: Patients with active infection. Patient conditions where there is insufficient quantity or quality of bone to support the device Patients with perforations in the mandibular fossa and/or bony deficiencies in the articular eminence compromising support for the artificial fossa component. Patients with mandibular and/or zygomatic arch screw holes compromising component fixation Patients requiring partial joint reconstruction or other TMJ procedures not listed as an indication. Patients who are NOT skeletally mature. Patients who are incapable or unwilling to follow postoperative care instructions. Patients who are unable to return for follow-up examinations. Patients with severe hyper-functional habits Patients on chronic steroid therapy.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Biomet TMJ Replacement System<br>All patients required total reconstruction of the temporomandibular joint (unilateral or billateral) | Device: Biomet TMJ Replacement System<br>* Total replacement of the temporomandibular joint with a Biomet TMJ Replacement System<br>* Other names: TMJ alloplastic reconstruction;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Revision | Time from surgical alloplastic reconstruction of the TMJ to revision surgery (Re-operation or removal) | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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. | 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 | 6 months, 1 year, 1.5 years, and 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patients requiring total joint reconstruction due to:, Arthritis (osteo-, rheumatoid, traumatic) malignancy, Ankylosis functional deformity, Avascular necrosis revisions, Benign neoplasms fracture, Multiple operated joints