Gruisen Jane A E, Punt Ilona M, Siskey Ryan, Emans Pieter, Dias Aylvin, Poeze Martijn, Roth Alex K
Maastricht University Medical Centre, Department of Trauma and Orthopedic Surgery, Maastricht, the Netherlands.
Exponent Inc., Engineering and Scientific Consulting, Philadelphia, Pennsylvania, USA.
J Biomed Mater Res B Appl Biomater. 2025 Apr;113(4):e35579. doi: 10.1002/jbm.b.35579.
Wear particles invariably form due to contact and friction between articulating surfaces in orthopedic prosthetic joint replacements. Polycarbonate urethane (PCU) has shown low wear rates and invoked minimal local biological response to wear debris in various orthopedic applications. However, controlled preclinical studies have not yet studied the biological response to PCU particles in synovial joints. This study aims to evaluate the biological response to mostly submicron-sized PCU wear particles in synovial joints in a rabbit model representing a worst-case scenario. PCU and ultra-high-molecular-weight-polyethene (UHMWPE) particles were generated in vitro, and particle characterization was performed using scanning electron microscopy (SEM) images. Fifteen New Zealand white rabbits, divided into three groups, received bilateral injections in the knee joint with 10 mg/mL PCU, UHMWPE particles, or saline (all 0.2 mL). After 3 months, the biological response in the joint was evaluated by histopathological reactivity scoring. The generated PCU and UHMWPE wear particles were mainly in the biologically active size range with an average equivalent circle diameter (ECD) of 0.31 μm (±0.48) and 6.99 μm (±16.32), respectively. There was a minimal to non-existing biological response (score ≤ 0.5) to PCU (0.5 ± 1.0), UHMWPE particles (0.6 ± 1.3) and saline (0.0 ± 0.0). Also, the wear particles did not disperse from the injection site. The results of this study support the use of PCU as a bearing surface in orthopedic prosthetic joint replacements by indicating that even in the likelihood that wear particles are generated, they are not likely to trigger a strong inflammatory response.
在骨科人工关节置换中，关节表面的接触和摩擦总会产生磨损颗粒。聚碳酸酯聚氨酯（PCU）在各种骨科应用中显示出低磨损率，并且对磨损颗粒引起的局部生物反应极小。然而，对照的临床前研究尚未研究滑膜关节对PCU颗粒的生物反应。本研究旨在评估在代表最坏情况的兔模型中，滑膜关节对主要为亚微米级PCU磨损颗粒的生物反应。体外生成PCU和超高分子量聚乙烯（UHMWPE）颗粒，并使用扫描电子显微镜（SEM）图像进行颗粒表征。15只新西兰白兔分为三组，膝关节双侧注射10mg/mL的PCU、UHMWPE颗粒或生理盐水（均为0.2mL）。3个月后，通过组织病理学反应评分评估关节中的生物反应。生成的PCU和UHMWPE磨损颗粒主要处于生物活性尺寸范围内，平均等效圆直径（ECD）分别为0.31μm（±0.48）和6.99μm（±16.32）。对PCU（0.5±1.0）、UHMWPE颗粒（0.6±1.3）和生理盐水（0.0±0.0）的生物反应极小至不存在（评分≤0.5）。此外，磨损颗粒未从注射部位扩散。本研究结果支持将PCU用作骨科人工关节置换的承重表面，表明即使有可能产生磨损颗粒，它们也不太可能引发强烈的炎症反应。
