Avascular Necrosis, Osteoarthritis, Rheumatoid Arthritis
Conditions
Keywords
hip resurfacing, osteoarthritis, avascular necrosis, rheumatoid arthritis
Brief 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.
Interventions
DEVICECormet Hip Resurfacing System
Cormet Hip Resurfacing System
Sponsors
Corin
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
* none
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| to monitor the clinical performance of the Cormet implant system for a period of up to 10 years postoperative in order to confirm that there are no unexpected reductions in device performance following PMA approval | 10 years |
Secondary
| Measure | Time frame |
|---|---|
| Harris Hip Score components including total score, pain, function and range of motion | 10 years |
| device survival | 10 years |
| device related adverse events | 10 years |
| radiographic evaluation including radiolucencies, component migration, and femoral subsidence and tilt | 10 years |
| whole blood trace metals and renal function | 10 years |
Countries
United States
Outcome results
None listed