Osteoarthritis Clinical Trial
Official title:
Post Approval Study of the C2a-Taper™ Acetabular System
The objective of this study is to gather clinical and survivorship information for the C2a-Taper™ Acetabular System, a ceramic-on-ceramic hip articulating system.
Study Design:
Phase 1
Sites will collect the following types of data:
Clinical-Total Harris Hip Score, Radiographic Evaluation- measurements on acetabular and
femoral components Survivorship-removal/revision of one or more components (i.e. liner,
head, shell and/or stem) Safety- All other adverse events
Follow-up Visit schedule
- 6 week ± 2 weeks
- 6 month ± 1 month
- 1 year ± 3 months
- 2 years ± 3 months
- 3 years ± 3 months
- 4 years ± 3 months
- 5 years ± 3 months
Phase 2:
Patients continue to be followed on an annual basis (Years 6-10) via mail. A self assessment
form is sent directly to the subject on an annual basis starting in the 6th post-operative
year.
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