Status:
COMPLETED
Total Temporomandibular Joint Replacement System Post Approval Study
Lead Sponsor:
Zimmer Biomet
Conditions:
Arthroplasty
Eligibility:
All Genders
18+ years
Brief Summary
Post-Approval Study (PMA CoA) in Order to Obtain Additional Long Term Safety and Effectiveness Data \[PMA P020016\]
Detailed Description
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 \[PMA P020016\].
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 21 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 21 2008
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT00762944
Start Date
September 21 2005
End Date
September 21 2008
Last Update
June 21 2024
Active Locations (4)
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1
Riley Hospital
Indianapolis, Indiana, United States, 46202
2
Jeffrey S. Topf, D.D.S.
West Bloomfield, Michigan, United States, 48322
3
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
4
The University of Texas,Southwestern Medical School
Dallas, Texas, United States, 75390