Trials / Completed
CompletedNCT00721994
Post-PMA Approval Study: 10 Year Follow-Up IDE Subjects
Cormet Resurfacing Hip System Post PMA Approval Study (PMA #P050016)Pre-market (IDE) Study Group 10 Year Follow-Up With Metal Ion and Renal Function Data Collection Clinical Investigation Plan
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 231 (actual)
- Sponsor
- Corin · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
primary endpoint of this Study is maintenance of "at least good clinical status" for a period of 10 years following initial implantation among Cormet procedures enrolled inthe pre-market IDE.
Detailed description
Maintaining "at least good clinical status" will be determined based upon the composite clinical success (CCS) criterion which includes no revision, removal, or replacement of any device component and a Harris Hip Total score of greater or equal to 80 points.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Cormet Hip Resurfacing System | Cormet Hip Resurfacing System |
Timeline
- Start date
- 2008-05-01
- Primary completion
- 2017-06-01
- Completion
- 2017-08-01
- First posted
- 2008-07-25
- Last updated
- 2018-11-21
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00721994. Inclusion in this directory is not an endorsement.