Podcast
Questions and Answers
What clearance process allowed the ASR XL total hip replacement to be marketed without clinical trials?
What clearance process allowed the ASR XL total hip replacement to be marketed without clinical trials?
- Post-market surveillance
- In vitro wear testing
- 510(k) clearance (correct)
- Pre-clinical testing
Which institution conducted in vitro wear testing on the ASR resurfacing at 55° inclination?
Which institution conducted in vitro wear testing on the ASR resurfacing at 55° inclination?
- BSI
- Leeds University (correct)
- DePuy
- Arthroplasty registers
What is the average wear of ASR resurfacing explants per year?
What is the average wear of ASR resurfacing explants per year?
- 18mm3/year (correct)
- 90mm3/year
- 55mm3/year
- 9mm3/year
How many steps do resurfacing patients do per year on average?
How many steps do resurfacing patients do per year on average?
What is the reported result from laboratory wear testing of the ASR XL total hip replacement?
What is the reported result from laboratory wear testing of the ASR XL total hip replacement?
Who is responsible for the post-market surveillance of the ASR XL total hip replacement?
Who is responsible for the post-market surveillance of the ASR XL total hip replacement?
What testing process did the ASR XL total hip replacement undergo prior to being fitted by surgeons?
What testing process did the ASR XL total hip replacement undergo prior to being fitted by surgeons?
What noteworthy feature characterizes the ASR resurfacing wear testing at 55° inclination compared to large ASRs at 45°?
What noteworthy feature characterizes the ASR resurfacing wear testing at 55° inclination compared to large ASRs at 45°?
'Substantial equivalence' is a concept closely related to which regulatory approval process in the United States?
'Substantial equivalence' is a concept closely related to which regulatory approval process in the United States?
'Revision rates' in the context of metal-on-metal hips refer to what specific aspect?
'Revision rates' in the context of metal-on-metal hips refer to what specific aspect?
