“优质”关节植入物是否有附加值？：社区注册研究中高成本关节植入物的分析。
Do "premium" joint implants add value?: analysis of high cost joint implants in a community registry.
机构信息
Department of Orthopaedic Surgery, University of Minnesota Medical School, Minneapolis, MN, USA.
出版信息
Clin Orthop Relat Res. 2011 Jan;469(1):48-54. doi: 10.1007/s11999-010-1436-z.
BACKGROUND
Numerous joint implant options of varying cost are available to the surgeon, but it is unclear whether more costly implants add value in terms of function or longevity.
QUESTIONS/PURPOSES: We evaluated registry survival of higher-cost "premium" knee and hip components compared to lower-priced standard components.
METHODS
Premium TKA components were defined as mobile-bearing designs, high-flexion designs, oxidized-zirconium designs, those including moderately crosslinked polyethylene inserts, or some combination. Premium THAs included ceramic-on-ceramic, metal-on-metal, and ceramic-on-highly crosslinked polyethylene designs. We compared 3462 standard TKAs to 2806 premium TKAs and 868 standard THAs to 1311 premium THAs using standard statistical methods.
RESULTS
The cost of the premium implants was on average approximately $1000 higher than the standard implants. There was no difference in the cumulative revision rate at 7-8 years between premium and standard TKAs or THAs.
CONCLUSIONS
In this time frame, premium implants did not demonstrate better survival than standard implants. Revision indications for TKA did not differ, and infection and instability remained contributors. Longer followup is necessary to demonstrate whether premium implants add value in younger patient groups.
LEVEL OF EVIDENCE
Level III, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.
背景
外科医生有多种不同成本的关节植入物可供选择，但尚不清楚更昂贵的植入物在功能或寿命方面是否具有更高的价值。
问题/目的：我们评估了高成本“优质”膝关节和髋关节组件相对于低价格标准组件的登记存活率。
方法
优质 TKA 组件的定义为活动衬垫设计、高屈曲度设计、氧化锆设计、包括适度交联聚乙烯插入物的组件，或某些组合。优质 THA 包括陶瓷对陶瓷、金属对金属和陶瓷对高交联聚乙烯设计。我们使用标准统计方法比较了 3462 例标准 TKA 与 2806 例优质 TKA，以及 868 例标准 THA 与 1311 例优质 THA。
结果
优质植入物的成本平均比标准植入物高出约 1000 美元。在 7-8 年时，优质和标准 TKA 或 THA 的累积翻修率没有差异。
结论
在这个时间范围内，优质植入物并没有比标准植入物表现出更好的存活率。TKA 的翻修指征没有差异，感染和不稳定仍然是主要原因。需要更长的随访时间来证明在年轻患者群体中优质植入物是否具有更高的价值。
证据水平
III 级，治疗性研究。有关证据水平的完整描述，请参见作者指南。
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