可生物降解骨科植入物的研究进展:文献综述。

IF 1.1 4区 医学 Q3 ORTHOPEDICS
Indian Journal of Orthopaedics Pub Date : 2025-06-22 eCollection Date: 2025-08-01 DOI:10.1007/s43465-025-01445-y
Anil Kumar Kotteda, Talari Saikumar, Akshay A Shreegan
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引用次数: 0

摘要

背景:可生物降解的骨科植入物已经成为传统的永久性金属或惰性聚合物植入物的创新替代品,旨在在关键的愈合阶段提供机械支持,随后在体内降解。它们的主要优势在于不需要进行第二次手术来移除硬件,从而潜在地降低了患者的发病率和医疗保健成本。尽管有这些好处,但与不可预测的降解动力学、机械强度和生物相容性相关的挑战限制了它们的广泛临床应用。方法:本综述综合了生物可降解骨科植入物的历史发展,所研究的生物材料范围-包括聚合物(如PLA, PLGA),金属(如Mg, Fe, Zn)和生物陶瓷(如HA, TCP)-以及所使用的制造技术,如挤出,注射成型和先进的增材制造。我们在Pubmed, Scopus, b谷歌scholar和Science direct等主要数据库中进行了搜索。我们考虑的是从1985年到2024年发表的文章。我们使用了包含医学主题标题(MeSH)的搜索策略。以下关键词使用了“可生物降解骨科植入物”、“可吸收植入物”、“可吸收固定装置”、“聚乳酸(PLA)”、“PLGA”、“聚己内酯(PCL)”、“镁合金”、“锌合金”、“生物陶瓷”、“磷酸三钙”、“骨折固定”、“植入物降解”、“腐蚀”、“水解降解”、“生物相容性”、“炎症反应”、“毒理学”、“FDA指南”、“可生物降解植入物批准”、“临床试验”、“长期结果”、“时间监视”。布尔运算符AND和OR用于组合关键词(例如,“生物可降解植入物”和“镁合金”和“骨折固定”)。筛选器用于选择仅以英文发表的文章。研究了不同材料类别的降解机制,以及临床前和临床发现。还分析了监管指南和正在进行的创新,包括多功能(例如,给药)和智能可生物降解植入物。结果:研究结果表明,可生物降解聚合物具有良好的降解特征,并已成功用于低负荷应用,包括儿科骨折固定和韧带修复。镁基和铁基合金在承载环境中显示出前景,尽管控制腐蚀仍然是一个持续的挑战。结合金属、聚合物和陶瓷的复合方法可以更好地定制机械性能和降解率,以满足特定的临床需求。早期临床结果通常显示骨折固定、脊柱手术和颌面手术的良好结果;然而,长期数据和大规模试验仍然有限。结论:可生物降解植入物代表了骨科护理的变革一步,提供了减少植入物相关并发症和二次手术的潜力。材料科学、制造和表面工程的持续创新对于解决当前降解控制、机械完整性和生物相容性方面的挑战至关重要。随着监管框架的成熟和成本障碍的减少,可生物降解的植入物有望成为肌肉骨骼修复的支柱,最终向更多的患者特异性和再生疗法发展。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Advancements in Biodegradable Orthopaedic Implants: A Literature Review.

Background: Biodegradable orthopaedic implants have emerged as an innovative alternative to traditional permanent metallic or inert polymer implants, aiming to provide mechanical support during critical healing phases and subsequently degrade in vivo. Their primary advantage lies in eliminating the need for a second surgery to remove hardware, thus potentially reducing patient morbidity and healthcare costs. Despite these benefits, challenges related to unpredictable degradation kinetics, mechanical strength, and biocompatibility have restricted their widespread clinical application.

Methods: This review synthesizes existing literature on the historical development of biodegradable orthopaedic implants, the range of biomaterials investigated-including polymers (e.g., PLA, PLGA), metals (e.g., Mg, Fe, Zn), and bio ceramics (e.g., HA, TCP)-and the manufacturing techniques used, such as extrusion, injection molding, and advanced additive manufacturing. We have searched across major databases like Pubmed, Scopus, Google scholar and Science direct. We considered the articles published from 1985 till 2024. We used the search strategy incorporating the Medical Subject headings(MeSH).The following keywords were used "biodegradable orthopedic implants", "resorbable implants", "absorbable fixation devices", "polylactic acid(PLA)", "PLGA", "Polycaprolactone(PCL)", "Magnesium alloys", "zinc alloys", "bioceramics", "tricalcium phosphate", "fracture fixation", "implant degradation", "corrosion", "hydrolytic degradation", "biocompatibility", "inflammatory response", "toxicology", "FDA guidelines", "biodegradable implant approval", "clinical trials", "long-term outcomes", "postmarket surveillance". Boolean operators AND and OR were used to combine keywords (e.g., "biodegradable implants" AND "magnesium alloys" AND "fracture fixation"). Filters were used to select the articles published only in English. The mechanisms of degradation for different material classes were examined, alongside preclinical and clinical findings. Regulatory guidelines and ongoing innovations, including multifunctional (e.g., drug-delivering) and smart biodegradable implants, were also analysed.

Results: Findings indicate that biodegradable polymers offer well-characterized degradation profiles and have been successfully used in lower-load applications, including paediatric fracture fixation and ligament repairs. Magnesium- and iron-based alloys show promise in load-bearing contexts, although controlling corrosion remains an ongoing challenge. Composite approaches that integrate metals, polymers, and ceramics can better tailor mechanical properties and degradation rates to specific clinical needs. Early clinical results generally demonstrate favourable outcomes in fracture fixation, spinal surgery, and maxillofacial procedures; however, long-term data and large-scale trials are still limited.

Conclusion: Biodegradable implants represent a transformative step in orthopaedic care, offering the potential to reduce implant-related complications and secondary procedures. Continued innovations in material science, manufacturing, and surface engineering will be crucial to address current challenges around degradation control, mechanical integrity, and biocompatibility. As the regulatory framework matures and cost barriers diminish, biodegradable implants are poised to become a mainstay in musculoskeletal repair, ultimately advancing toward more patient-specific and regenerative therapies.

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来源期刊
CiteScore
1.80
自引率
0.00%
发文量
185
审稿时长
9 months
期刊介绍: IJO welcomes articles that contribute to Orthopaedic knowledge from India and overseas. We publish articles dealing with clinical orthopaedics and basic research in orthopaedic surgery. Articles are accepted only for exclusive publication in the Indian Journal of Orthopaedics. Previously published articles, articles which are in peer-reviewed electronic publications in other journals, are not accepted by the Journal. Published articles and illustrations become the property of the Journal. The copyright remains with the journal. Studies must be carried out in accordance with World Medical Association Declaration of Helsinki.
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