如何最好地规范市场上的新植入物——放射立体分析就足够了吗?

IF 0.5 4区 医学 Q4 ORTHOPEDICS Annals of Joint Pub Date : 2019-04-12 DOI:10.21037/aoj.2019.11.01
B. Kendrick, A. Palmer, A. Taylor
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引用次数: 2

摘要

现代患者的需求,无论是髋关节置换术能让他们做什么,还是能持续多久,都意味着上市前的测试和密切监测应该是强有力的,以避免以前植入的问题。短期内失败的植入物相对容易检测。植入物在中长期内失败,但比同类植入物更快或更具破坏性,更难识别。如果时间和资源不受限制,那么在释放前评估新植入物的最佳策略是什么?新的植入物是否只有在经过详细评估和长期随访的小组中仔细引入后才能向所有外科医生发放?足够的随访时间是多长?
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How best to regulate new implants in the market—is radiostereometric analysis enough?
The demands of the modern patient, both in terms of what a hip replacement will allow them to do as well as for how long it will last, mean that pre-market testing and close surveillance should be robust to avoid the problems of previous implants. Implants that fail in the short-term are relatively easy to detect. Implants that fail in the medium to long-term, but sooner or in more damaging modes than their peers, are much more difficult to identify. What would be the optimal strategy to evaluate a new implant prior to release if time and resource was unlimited? Would the new implant only be released to all surgeons after careful introduction in a small cohort with detailed assessment and extended follow-up? How long is sufficient follow-up?
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来源期刊
Annals of Joint
Annals of Joint ORTHOPEDICS-
CiteScore
1.10
自引率
-25.00%
发文量
17
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