Trials / Completed
CompletedNCT00762944
Total Temporomandibular Joint Replacement System Post Approval Study
Survivibility of the Total Temporomandibular Joint Replacement System
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 93 (actual)
- Sponsor
- Zimmer Biomet · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 \[PMA P020016\].
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Biomet TMJ Replacement System | Total replacement of the temporomandibular joint with a Biomet TMJ Replacement System |
Timeline
- Start date
- 2005-09-21
- Primary completion
- 2008-08-25
- Completion
- 2008-09-21
- First posted
- 2008-09-30
- Last updated
- 2024-06-21
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT00762944. Inclusion in this directory is not an endorsement.