{"title":"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?","authors":"B. Kendrick, A. Palmer, A. Taylor","doi":"10.21037/aoj.2019.11.01","DOIUrl":null,"url":null,"abstract":"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?","PeriodicalId":44459,"journal":{"name":"Annals of Joint","volume":" ","pages":""},"PeriodicalIF":0.5000,"publicationDate":"2019-04-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"2","resultStr":"{\"title\":\"How best to regulate new implants in the market—is radiostereometric analysis enough?\",\"authors\":\"B. Kendrick, A. Palmer, A. Taylor\",\"doi\":\"10.21037/aoj.2019.11.01\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"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?\",\"PeriodicalId\":44459,\"journal\":{\"name\":\"Annals of Joint\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":0.5000,\"publicationDate\":\"2019-04-12\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"2\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Annals of Joint\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.21037/aoj.2019.11.01\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"ORTHOPEDICS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Annals of Joint","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.21037/aoj.2019.11.01","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"ORTHOPEDICS","Score":null,"Total":0}
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?