Popoola Oludele O, Kincaid Brian L, Mimnaugh Kimberly, Marqueling Mark
Zimmer Biomet Research, Warsaw, IN, USA.
Zimmer Biomet Research, Warsaw, IN, USA.
J Shoulder Elbow Surg. 2017 May;26(5):846-854. doi: 10.1016/j.jse.2016.12.066. Epub 2017 Feb 5.
The objectives of this study were to develop a clinically relevant in vitro elbow wear test and to compare the polyethylene wear of 2 total elbow replacement prostheses, one that uses conventional gamma-irradiated polyethylene (CPE) and one that uses vitamin E blended and cross-linked polyethylene (VE-HXPE) bushings.
The test protocol applied 0° to 85° flexion-extension motions and imposed a constant 4.5° varus malalignment of the ulnar relative to the humeral implant under a variable joint load profile at a frequency of 1 Hz. The implants were tested for 3 million cycles (Mc) in a bovine serum lubricant at 37°C ± 3°C. Polyethylene wear was determined gravimetrically. Wear particles were isolated and characterized.
Clinically relevant polyethylene bushings wear mechanisms were observed. After 3 Mc, the mean CPE wear rate was 9.3 ± 2.8 mm/Mc, significantly lower than that reported for hip and knee implants but comparable to that of ankle (7.4 ± 1.3 mm/Mc) devices. The mean VE-HXPE wear rate was 0.8 ± 0.2 mm/Mc, comparable to that of hip and knees devices. The mean equivalent circle diameter and aspect ratio were 0.17 ± 0.01 µm and 1.99 ± 0.18 for the CPE and 0.15 ± 0.02 µm and 1.81 ± 0.16 for the VE-HXPE particles.
The test replicated clinically observed failure modes for CPE devices. The use of VE-HXPE led to an order of magnitude reduction in polyethylene wear. Further clinical evaluation is necessary to determine if this translates into reduced complications of total elbow replacement associated with wear.
本研究的目的是开发一种具有临床相关性的体外肘部磨损试验,并比较两种全肘关节置换假体的聚乙烯磨损情况,一种使用传统的γ射线辐照聚乙烯(CPE),另一种使用维生素E混合交联聚乙烯(VE-HXPE)衬套。
试验方案采用0°至85°屈伸运动,并在1Hz频率下,在可变关节负荷曲线下,使尺骨相对于肱骨植入物保持恒定4.5°的内翻畸形。植入物在37°C±3°C的牛血清润滑剂中进行300万次循环(Mc)测试。通过重量法测定聚乙烯磨损情况。分离并表征磨损颗粒。
观察到具有临床相关性的聚乙烯衬套磨损机制。300万次循环后,CPE的平均磨损率为9.3±2.8mm/Mc,显著低于髋关节和膝关节植入物的报道,但与踝关节(7.4±1.3mm/Mc)装置相当。VE-HXPE的平均磨损率为0.8±0.2mm/Mc,与髋关节和膝关节装置相当。CPE颗粒的平均等效圆直径和长宽比分别为0.17±0.01μm和1.99±0.18,VE-HXPE颗粒的平均等效圆直径和长宽比分别为0.15±0.02μm和1.81±0.16。
该试验复制了CPE装置临床观察到的失效模式。VE-HXPE的使用使聚乙烯磨损降低了一个数量级。需要进一步的临床评估来确定这是否能转化为全肘关节置换中与磨损相关的并发症减少。