Miller Andrew, Jeyapalina Sujee, Agarwal Jayant P, Beck James Peter
Research, George E. Wahlen Department of Veteran Affairs Medical Center, Salt Lake City, Utah, USA.
Department of Surgery, Division of Plastic and Reconstructive Surgery, University of Utah, School of Medicine, Salt Lake City, Utah, USA.
J Biomed Mater Res B Appl Biomater. 2024 Mar;112(3):e35398. doi: 10.1002/jbm.b.35398.
Patients implanted with osseointegrated (OI) prosthetic systems have reported vastly improved upper and lower extremity prosthetic function compared with their previous experience with socket-suspension systems. However, OI systems have been associated with superficial and deep-bone infections and implant loosening due, in part, to a failure of the osseointegration process. Although monitoring the osseointegration using circulating biomarkers has clinical relevance for understanding the progression of osseointegration with these devices, it has yet to be established. Ten patients were enrolled in this study. Blood samples were collected at pre-selected times, starting before implantation surgery, and continuing to 12 months after the second surgery. Bone formation markers, bone resorption markers, and circulating amino acids were measured from blood samples. A linear mixed model was generated for each marker, incorporating patient ID and age with the normalized marker value as the response variable. Post hoc comparisons were made between 1 week before Stage 1 Surgery and all subsequent time points for each marker, followed by multiple testing corrections. Serial radiographic imaging of the residual limb containing the implant was obtained during follow-up, and the cortical index (CI) was calculated for the bone at the porous region of the device. Two markers of bone formation, specifically bone-specific alkaline phosphatase (Bone-ALP) and amino-terminal propeptide of type I procollagen (PINP), exhibited significant increases when compared with the baseline levels of unloaded residual bone prior to the initial surgery, and they subsequently returned to their baseline levels by the 12-month mark. Patients who experienced clinically robust osseointegration experienced increased cortical bone thickness at the porous coated region of the device. A medium correlation was observed between Bone-ALP and the porous CI values up to PoS2-M1 (p = .056), while no correlation was observed for PINP. An increase in bone formation markers and the lack of change observed in bone resorption markers likely reflect increased cortical bone formation induced by the end-loading design of the Utah OI device used in this study. A more extensive study is required to validate the correlation observed between Bone-ALP and porous CI values.
与之前使用套接悬吊系统的经历相比，植入骨整合（OI）假体系统的患者报告称其上下肢假体功能有了极大改善。然而，OI系统与浅表和深部骨感染以及种植体松动有关，部分原因是骨整合过程失败。尽管使用循环生物标志物监测骨整合对于理解这些装置的骨整合进展具有临床意义，但尚未得到证实。本研究招募了10名患者。在预先选定的时间采集血样，从植入手术前开始，一直持续到第二次手术后12个月。从血样中测量骨形成标志物、骨吸收标志物和循环氨基酸。为每个标志物生成一个线性混合模型，将患者ID和年龄与标准化标志物值作为响应变量纳入其中。对每个标志物在第1阶段手术前1周与所有后续时间点进行事后比较，随后进行多重检验校正。在随访期间对包含植入物的残肢进行系列放射成像，并计算装置多孔区域骨的皮质指数（CI）。与初始手术前未负重残骨的基线水平相比，两种骨形成标志物，即骨特异性碱性磷酸酶（Bone-ALP）和I型前胶原氨基端前肽（PINP）显著升高，随后在12个月时恢复到基线水平。经历临床强健骨整合的患者在装置多孔涂层区域的皮质骨厚度增加。在PoS2-M1之前，Bone-ALP与多孔CI值之间观察到中等相关性（p = 0.056），而PINP未观察到相关性。骨形成标志物的增加以及骨吸收标志物未观察到变化可能反映了本研究中使用的犹他OI装置的末端加载设计诱导的皮质骨形成增加。需要进行更广泛的研究来验证Bone-ALP与多孔CI值之间观察到的相关性。
