Total Temporomandibular Joint Replacement System Post Approval Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

93 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-09-21

Study Completion Date

2008-09-21

Brief Summary

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

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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 \[PMA P020016\].

Conditions

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Arthroplasty

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Biomet TMJ Replacement System

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

Biomet TMJ Replacement System

Intervention Type DEVICE

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

Interventions

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Biomet TMJ Replacement System

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

Intervention Type DEVICE

Other Intervention Names

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TMJ alloplastic reconstruction

Eligibility Criteria

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Inclusion Criteria

1. Patients requiring total joint reconstruction due to:

Arthritis (osteoarthritis, rheumatoid, traumatic) malignancy Ankylosis functional deformity Avascular necrosis revisions Benign neoplasms fracture Multiple operated joints
2. Patients who are skeletally mature.
3. Patients must have at least one of the following criteria for surgical TMJ treatment.

1. Presence of considerable pain and/or limited function in the joint area.
2. Clinical and imaging evidence consistent with anatomic joint pathology
3. Previous failure of non-surgical treatment/therapy or a failed implant.
4. High probability of patient improvement by surgical treatment.
4. Patients must be able to return for follow-up examinations.
5. Patients without serious compromising general medical conditions.

Exclusion Criteria

1. Patients with active infection.
2. Patient conditions where there is insufficient quantity or quality of bone to support the device
3. Patients with perforations in the mandibular fossa and/or bony deficiencies in the articular eminence compromising support for the artificial fossa component.
4. Patients with mandibular and/or zygomatic arch screw holes compromising component fixation
5. Patients requiring partial joint reconstruction or other TMJ procedures not listed as an indication.
6. Patients who are NOT skeletally mature.
7. Patients who are incapable or unwilling to follow postoperative care instructions.
8. Patients who are unable to return for follow-up examinations.
9. Patients with severe hyper-functional habits
10. Patients on chronic steroid therapy.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No