van Duren Bernard H, France Jonathan, Berber Reshid, Matar Hosam E, James Peter J, Bloch Benjamin V
Nottingham Elective Orthopaedic Services, Nottingham University Hospitals NHS Trust, Nottingham, NG5 1PB, UK.
Leeds Orthopaedic and Trauma Sciences, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, LS2 9JT, UK.
Arthroplasty. 2024 Aug 3;6(1):46. doi: 10.1186/s42836-024-00264-0.
The Attune TKR was introduced in 2011 as a successor to its predicate design The PFC Sigma. However, following reports of early failures, there are ongoing concerns related to increased loosening rates. Given the concerns, this study aimed to compare revision rates of the Attune implant to an established predicate, and other implant designs used in a high-volume arthroplasty center.
We identified 10,202 patients who underwent primary cemented TKR at our institution with a minimum of 1 year follow-up, involving 2406 Attune TKR (557 S +), 4642 PFC TKR, 3154 other designs. Primary outcomes were revision for all-causes, aseptic loosening of any component, and aseptic tibial loosening. Kaplan-Meier survival and Cox regression models were used to compare groups. Matched cohorts were selected for radiographic analysis.
308 knees were revised. The Attune cohort had the lowest risk of revision, with a rate of 2.98 per 1000 implant-years while the PFC and All Other Implant groups had a rate of 3.15 and 4.4 respectively. Aseptic loosing was the most common cause for revision, with 76% (65/88) involving the tibia. Survival analysis showed no significant differences between the Attune and other cohorts. Radiolucent lines were detected in 7.1% of the Attune S + group, 6.8% of the standard Attune group, and 6.3% of the PFC group, with no significant differences found between them.
This study represents the largest non-registry review of the Attune TKR in comparison to a predicate and other designs. There was no significant increased revision rate for all-cause revision or aseptic loosening, or peri-implant radiolucencies. It appears that increased loosening may not be as concerning as originally thought.
Level III.
Attune全膝关节置换术（TKR）于2011年推出，作为其前代产品PFC Sigma的继任者。然而，在有早期失败的报告后，人们一直担心其松动率增加。鉴于这些担忧，本研究旨在比较Attune植入物与一种既定前代产品以及在一个高容量关节置换中心使用的其他植入物设计的翻修率。
我们确定了10202例在我们机构接受初次骨水泥固定TKR的患者，至少随访1年，其中包括2406例Attune TKR（557例S+型）、4642例PFC TKR、3154例其他设计。主要结局是全因翻修、任何组件的无菌性松动和无菌性胫骨松动。采用Kaplan-Meier生存分析和Cox回归模型比较各组。选择匹配队列进行影像学分析。
308例膝关节进行了翻修。Attune队列的翻修风险最低，每1000植入年的翻修率为2.98，而PFC和所有其他植入物组的翻修率分别为3.15和4.4。无菌性松动是翻修的最常见原因，76%（65/88）涉及胫骨。生存分析显示Attune组与其他队列之间无显著差异。在Attune S+组中，7.1%检测到透光线，标准Attune组为6.8%，PFC组为6.3%，它们之间无显著差异。
与前代产品和其他设计相比，本研究是对Attune TKR进行的最大规模的非注册研究。全因翻修、无菌性松动或植入物周围透光线的翻修率没有显著增加。看来松动增加可能不像最初认为的那么令人担忧。
III级。
