Trials / Terminated
TerminatedNCT00715143
Post Approval Study: NOVATION Ceramic Articulation Hip System
Post Approval Study: NOVATION Ceramic Articulation Hip System A Multi-Center, Open-Label Study to Evaluate the Mid and Long-Term Safety and Effectiveness of the Exactech NOVATION Ceramic Articulation Hip System
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 126 (actual)
- Sponsor
- Exactech · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to collect and evaluate long-term safety and effectiveness data on the Exactech® NOVATION ™ Ceramic Articulation Hip System ("NOVATION ™ Ceramic AHS").
Detailed description
The purpose of this study is to collect and evaluate long-term safety and effectiveness data on the Exactech® NOVATION ™ Ceramic Articulation Hip System ("NOVATION ™ Ceramic AHS"). Ten (10) years of follow-up data will be collected in this study. The first five (5) years of subject follow-up will involve clinical (Harris Hip Score, adverse events), radiographic, and self-assessment evaluation. The remaining five (5) years of subject follow-up will be accomplished with an outcomes questionnaire that will be completed by the subjects to evaluate the survivorship status of their hip replacement.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Novation Ceramic | This treatment is the study device (which will be compared to a similar historic control device) |
Timeline
- Start date
- 2008-06-01
- Primary completion
- 2021-02-22
- Completion
- 2021-02-22
- First posted
- 2008-07-15
- Last updated
- 2022-08-31
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00715143. Inclusion in this directory is not an endorsement.