Mesh : Female Humans Middle Aged Arthroplasty, Replacement, Hip Hip Prosthesis / adverse effects Glomerular Filtration Rate Prospective Studies Metal-on-Metal Joint Prostheses / adverse effects Prosthesis Design Metals Cobalt Chromium

来  源:   DOI:10.1302/0301-620X.106B3.BJJ-2023-0849.R1

Abstract:
UNASSIGNED: The first aim of this study was to evaluate whether preoperative renal function is associated with postoperative changes in whole blood levels of metal ions in patients who have undergone a Birmingham Hip Resurfacing (BHR) arthroplasty with a metal-on-metal bearing. The second aim was to evaluate whether exposure to increased cobalt (Co) and chromium (Cr) levels for ten years adversely affected renal function.
UNASSIGNED: As part of a multicentre, prospective post-approval study, whole blood samples were sent to a single specialized laboratory to determine Co and Cr levels, and the estimated glomerular filtration rate (eGFR). The study included patients with 117 unrevised unilateral BHRs. There were 36 females (31%). The mean age of the patients at the time of surgery of 51.3 years (SD 6.5), and they all had preoperative one-, four-, five-, and ten-year laboratory data. The mean follow-up was 10.1 years (SD 0.2).
UNASSIGNED: Median Co levels at one year postoperatively increased significantly compared with the preoperative values, by a factor of 9.7, from 0.13 to 1.26 ppb (p < 0.001), and the median Cr levels increased significantly by a factor of 2.5, from 0.60 to 1.50 ppb (p < 0.001). Lower preoperative eGFRs were associated with significantly larger increases in Co at one year compared with the preoperative levels (ρ = -0.26; p = 0.005), but there was no relationship between preoperative eGFRs and changes in Cr at one year (ρ = -0.13; p = 0.153). Metal levels remained relatively constant with the passage of time, with a median ten-year value of 1.12 ppb for Co and 1.29 ppb for Cr. There was no significant relationship between the Co and Cr levels at ten-year follow-up and the change in eGFR from the preoperative level to that at ten years (ρ = -0.02; p = 0.827 for Co; ρ = -0.008; p = 0.933 for Cr).
UNASSIGNED: Although patients with lower preoperative eGFRs tended to have larger increases in Co levels at one year, increased metal levels for patients who underwent unilateral BHR did not adversely affect renal function during the first ten postoperative years.
摘要:
这项研究的第一个目的是评估在接受伯明翰髋关节表面置换术(BHR)并使用金属对金属轴承的患者中,术前肾功能是否与术后全血金属离子水平的变化有关。第二个目的是评估十年暴露于钴(Co)和铬(Cr)水平升高是否会对肾功能产生不利影响。
作为多中心的一部分,前瞻性批准后研究,全血样本被送到一个专门的实验室,以确定Co和Cr水平,和估计的肾小球滤过率(eGFR)。该研究包括117例未经修正的单侧BHR患者。有36名女性(31%)。手术时患者的平均年龄为51.3岁(SD6.5),他们都有术前一个-,four-,五-,和十年的实验室数据。平均随访时间为10.1年(SD0.2)。
术后1年Co水平中位数与术前相比明显增加,从0.13到1.26ppb(p<0.001),为9.7倍,和中位数Cr水平显着增加了2.5倍,从0.60到1.50ppb(p<0.001)。与术前水平相比,术前eGFRs较低与Co在一年内的显著增加相关(ρ=-0.26;p=0.005),但术前eGFRs与1年Cr的变化之间没有关系(ρ=-0.13;p=0.153)。随着时间的推移,金属水平保持相对恒定,Co的十年中位数为1.12ppb,Cr的十年中位数为1.29ppb。十年随访时的Co和Cr水平与eGFR从术前水平到十年时的变化之间没有显着关系(ρ=-0.02;Co的p=0.827;ρ=-0.008;Cr的p=0.933)。
尽管术前eGFRs较低的患者在一年时Co水平有较大的增加,在术后前10年,接受单侧BHR的患者的金属水平升高并未对肾功能产生不利影响.
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