Mineralized collagen-enhanced bone cement: A prospective, randomized controlled trial in total knee arthroplasty

IF 4.2 3区医学 Q2 ENGINEERING, BIOMEDICAL

Journal of Materials Science: Materials in Medicine Pub Date : 2025-05-15 DOI:10.1007/s10856-025-06893-4

Bin Feng, Zhanqi Wei, Wei Zhu, Yiming Xu, Zeng Li, Xisheng Weng

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引用次数: 0

Abstract

Total knee arthroplasty (TKA) is a common procedure for end-stage osteoarthritis (OA). Traditional polymethylmethacrylate (PMMA) bone cement used in TKA has limitations, including lack of osteointegration and higher modulus than bone. We developed a novel bone cement, mineralized collagen (MC)-PMMA, to address these issues. In a prospective, randomized controlled trial, we compared TKA outcomes using MC-PMMA versus traditional PMMA (T-PMMA) in 34 patients with bilateral late-stage osteoarthritis. Evaluated parameters included patient-reported outcome measures (PROMs), knee range of motion, pain scores, complications, and radiographic evaluations over a 45.8-month follow-up. The MC-PMMA group showed significantly improved Knee Society function scores at one-year follow-up. No significant differences were found between groups in other PROMs, knee range of motion, or pain scores. Radiographic evaluations revealed no differences in postoperative Hip-Knee-Ankle (HKA) angle, anatomical axis angle, or radiolucent lines. Complication rates were similar, with no infections, aseptic loosening, peri-prosthetic fractures, or revisions. MC-PMMA is a promising biomaterial for TKA, offering comparable safety and mid-term clinical outcomes to T-PMMA. Its use may lead to earlier functional recovery, highlighting the potential of nanomaterials in orthopedic applications. Trial registration number: ChiCTR1800014811 (02/07/2018).

Graphical Abstract

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矿化胶原增强骨水泥：全膝关节置换术的前瞻性随机对照试验

全膝关节置换术（TKA）是治疗终末期骨关节炎（OA）的常用方法。传统的聚甲基丙烯酸甲酯（PMMA）骨水泥用于TKA具有局限性，包括缺乏骨整合和比骨高的模量。我们开发了一种新型骨水泥，矿化胶原蛋白(MC)-PMMA，以解决这些问题。在一项前瞻性随机对照试验中，我们比较了34例双侧晚期骨关节炎患者使用MC-PMMA和传统PMMA （T-PMMA）的TKA结果。评估参数包括患者报告的结果测量（PROMs）、膝关节活动度、疼痛评分、并发症和45.8个月随访期间的影像学评估。MC-PMMA组在1年随访中膝关节社会功能评分显著改善。在其他PROMs、膝关节活动度或疼痛评分方面，两组间无显著差异。放射学评估显示术后髋关节-膝关节-踝关节（HKA）角度、解剖轴角度或放射透光线无差异。并发症发生率相似，无感染、无菌性松动、假体周围骨折或翻修。MC-PMMA是一种很有前途的TKA生物材料，具有与T-PMMA相当的安全性和中期临床结果。它的使用可能导致更早的功能恢复，突出了纳米材料在骨科应用中的潜力。试验注册号：ChiCTR1800014811（02/07/2018）。图形抽象

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来源期刊

Journal of Materials Science: Materials in Medicine 工程技术-材料科学：生物材料

CiteScore

8.00

自引率

0.00%

发文量

审稿时长

3.5 months

期刊介绍： The Journal of Materials Science: Materials in Medicine publishes refereed papers providing significant progress in the application of biomaterials and tissue engineering constructs as medical or dental implants, prostheses and devices. Coverage spans a wide range of topics from basic science to clinical applications, around the theme of materials in medicine and dentistry. The central element is the development of synthetic and natural materials used in orthopaedic, maxillofacial, cardiovascular, neurological, ophthalmic and dental applications. Special biomedical topics include biomaterial synthesis and characterisation, biocompatibility studies, nanomedicine, tissue engineering constructs and cell substrates, regenerative medicine, computer modelling and other advanced experimental methodologies.