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Sponsored by: |
Biomet, Inc. |
---|---|
Information provided by: | Biomet, Inc. |
ClinicalTrials.gov Identifier: | NCT00762944 |
Post-Approval Study (PMA CoA) in Order to Obtain Additional Long Term Safety and Effectiveness Data
Condition |
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Arthroplasty |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Total Temporomandibular Joint Replacement System Post Approval Study |
Enrollment: | 92 |
Study Start Date: | September 2005 |
Study Completion Date: | September 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients who received TMJ systems from the IDE study
Inclusion Criteria:
Patients requiring total joint reconstruction due to:
Arthritis (osteo-, rheumatoid, traumatic) malignancy Ankylosis functional deformity Avascular necrosis revisions Benign neoplasms fracture Multiple operated joints
Patients must have at least one of the following criteria for surgical TMJ treatment.
Exclusion Criteria:
United States, Indiana | |
Riley Hospital | |
Indianapolis, Indiana, United States | |
United States, Michigan | |
Jeffrey S. Topf, D.D.S. | |
West Bloomfield, Michigan, United States | |
United States, Pennsylvania | |
Hospital of the University of Pennsylvania | |
Philadelphia, Pennsylvania, United States | |
United States, Texas | |
The University of Texas,Southwestern Medical School | |
Dallas, Texas, United States |
Study Director: | Kim Reed | Biomet Microfixation |
Responsible Party: | Biomet Microfixation ( Kim Reed, Regulatory Affairs Manager ) |
Study ID Numbers: | BMET WL 01 |
Study First Received: | September 26, 2008 |
Last Updated: | September 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00762944 History of Changes |
Health Authority: | United States: Institutional Review Board |
Patients requiring total joint reconstruction due to: Arthritis (osteo-, rheumatoid, traumatic) malignancy Ankylosis functional deformity |
Avascular necrosis revisions Benign neoplasms fracture Multiple operated joints |
Necrosis Osteonecrosis Arthritis |
Fractures, Bone Congenital Abnormalities Ankylosis |