Total Temporomandibular Joint Replacement System Post Approval Study

Completed

Conditions studied: Arthroplasty

In brief

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

Key facts

Study ID

NCT00762944

Run by

Zimmer Biomet

People needed

93

Starts

2005-09-21

Expected to finish

2008-09-21

Last updated by the study team

2024-06-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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