University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, Fetscherstr. 74, 01307, Dresden, Germany.
Knee Surg Sports Traumatol Arthrosc. 2018 Nov;26(11):3459-3467. doi: 10.1007/s00167-018-4928-0. Epub 2018 Apr 3.
Patients with known hypersensitivity to metals often require hypoallergenic TKA implants. Coating of a standard implant is a common solution, and although in vitro tests have demonstrated reduction of polyethylene wear for these coatings, it is still unknown whether these implants have any clinical benefit. This study was initiated to investigate metal ion concentrations, knee function and patient-reported outcome (PRO) after coated and uncoated TKA.
One hundred and twenty-two (122) patients were randomized to receive a coated or a standard TKA and, after exclusions, 59 patients were included in each group. Knee function and PRO were assessed with validated scores up to 3 years after surgery. Metal ion concentrations in blood samples were determined for chromium, cobalt, molybdenum and nickel, preoperatively and 1 year after surgery.
Chromium concentrations in patient plasma increased from a median of 0.25 to 1.30 µg/l in the standard TKA group, and from 0.25 to 0.75 µg/l in the coated TKA group (p = 0.012). Thirteen patients (3 coated, 10 standard TKA) had chromium concentrations above 2 µg/l. The concentrations of cobalt, molybdenum and nickel did not change. Patient-reported outcome measures (PROM) demonstrated a substantial improvement after TKA, without any differences between the groups.
The increase in chromium concentration in the standard group needs further investigation. If surgeons use coated implants, they can be confident that these implants perform as well as standard implants.
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已知对金属过敏的患者通常需要使用低致敏性 TKA 植入物。对标准植入物进行涂层是一种常见的解决方案，尽管体外测试已经证明这些涂层可以减少聚乙烯磨损，但仍不清楚这些植入物是否具有任何临床益处。本研究旨在调查涂层和未涂层 TKA 后的金属离子浓度、膝关节功能和患者报告的结果 (PRO)。
122 名患者被随机分配接受涂层或标准 TKA，排除后每组 59 名患者纳入研究。手术后用经过验证的评分评估膝关节功能和 PRO，直至 3 年。在术前和手术后 1 年，分别从患者血液样本中测定铬、钴、钼和镍的金属离子浓度。
标准 TKA 组患者血浆中的铬浓度从中位数 0.25 增加到 1.30µg/l，涂层 TKA 组从 0.25 增加到 0.75µg/l（p=0.012）。13 名患者（3 名涂层，10 名标准 TKA）的铬浓度超过 2µg/l。钴、钼和镍的浓度没有变化。TKA 后患者报告的结果测量（PROM）有了显著改善，两组之间没有差异。
标准组铬浓度的增加需要进一步研究。如果外科医生使用涂层植入物，他们可以确信这些植入物与标准植入物一样有效。
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