Post-PMA Approval Study: 10 Year Follow-Up IDE Subjects
| Status: | Completed |
|---|---|
| Conditions: | Arthritis, Arthritis, Osteoarthritis (OA), Rheumatoid Arthritis, Orthopedic |
| Therapuetic Areas: | Rheumatology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/23/2018 |
| Start Date: | May 2008 |
| End Date: | August 2017 |
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
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.
of 10 years following initial implantation among Cormet procedures enrolled inthe pre-market
IDE.
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.
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.
Inclusion Criteria:
- subjects enrolled in the Cormet IDE study at the 5 identified clinical sites
- Individuals who agree to participate in the study by signing the informed patient
consent form
Exclusion Criteria:
We found this trial at
5
sites
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801 N Rutledge St
Springfield, Illinois 62702
Springfield, Illinois 62702
(217) 545-8000
Southern Illinois University School of Medicine At SIU School of Medicine, research includes biologically oriented...
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