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迷失在翻译中:外科医生和科学家在生物材料研究和治疗骨缺损创新方面缺乏共识。

Lost in translation: the lack of agreement between surgeons and scientists regarding biomaterials research and innovation for treating bone defects.

机构信息

Department of Orthopaedics and Trauma Surgery, Musculoskeletal University Center Munich (MUM), LMU University Hospital, LMU Munich, Munich, Germany.

Australian Research Council (ARC) Training Centre for Multiscale 3D Imaging, Modelling, and Manufacturing (M3D Innovation), Queensland University of Technology, Brisbane, QLD, 4000, Australia.

出版信息

BMC Med. 2024 Nov 6;22(1):517. doi: 10.1186/s12916-024-03734-z.

Abstract

BACKGROUND

With over 2 million grafts performed annually, bone ranks second only to blood in the frequency of transplants. This high demand is primarily driven by the persistent challenges posed by bone defects, particularly following trauma or surgical interventions such as tumour excision. The demand for effective and efficient treatments has increased exponentially in the twenty-first century. Limitations associated with autologous bone grafts drive exploration into replacements, including allografts, synthetic substitutes, and 3D-printed scaffolds. This research aimed to unravel disparities in the knowledge and evaluation of current and future bone defect treatments between surgeons and biomaterial scientists.

METHODS

A prospective cross-sectional survey, pre-registered with the OSF ( https://osf.io/y837m/?view_only=fab29e24df4f4adf897353ac70aa3361 ) and conducted online from October 2022 to March 2023, collected data on surgeons' views (n = 337) and scientists (n = 99) on bone defect treatments.

RESULTS

Scientists were significantly more optimistic than surgeons regarding the future replacement of autologous bone grafts with synthetic or tissue-engineered substitutes (p < 0.001). Accordingly, scientists foresee a paradigm shift from autologous bone grafts to biomaterial and tissue-engineered solutions, reflecting their confidence in the ongoing advancements within this field. Furthermore, regulatory trepidations for 3D-printed bone scaffolds were acknowledged, with scientists emphasizing the need for a more significant focus on clinical relevance in preclinical studies and regulatory clarity. In a ranked categorical assessment, witnessing the technology in action was deemed most influential in adopting new bone regeneration methods by both scientists and surgeons.

CONCLUSIONS

To conclude, this study was conducted through a web-based survey, highlighting a substantial translational gap. It underscores the immediate need ("call to action") for meaningful interdisciplinary collaboration between surgeons and scientists, often referred to as the need to "walk the talk". The findings underscore the critical importance of aligning clinical needs, research outcomes, and regulatory frameworks to improve the development and implementation of biomaterial-based bone graft substitutes that demonstrate efficacy and efficiency in bone defect treatment.

摘要

背景

每年进行的移植手术中,骨移植仅次于输血,位列第二。这种高需求主要是由骨缺损带来的持续挑战所驱动的,尤其是在创伤或手术干预(如肿瘤切除)之后。在 21 世纪,对有效和高效治疗方法的需求呈指数级增长。自体骨移植物的局限性促使人们探索替代品,包括同种异体移植物、合成替代品和 3D 打印支架。本研究旨在揭示外科医生和生物材料科学家对当前和未来骨缺损治疗方法的认识和评估之间的差异。

方法

一项前瞻性横断面调查,在 OSF 进行了预先注册(https://osf.io/y837m/?view_only=fab29e24df4f4adf897353ac70aa3361),并于 2022 年 10 月至 2023 年 3 月在线进行,收集了外科医生(n=337)和科学家(n=99)对骨缺损治疗的看法数据。

结果

科学家对未来用合成或组织工程替代品替代自体骨移植物的前景明显比外科医生更乐观(p<0.001)。因此,科学家们预见到从自体骨移植物向生物材料和组织工程解决方案的范式转变,反映了他们对该领域正在进行的进展的信心。此外,科学家们承认对 3D 打印骨支架的监管担忧,强调需要更加关注临床相关性,提高临床前研究和监管的清晰度。在排名分类评估中,科学家和外科医生都认为看到技术的实际应用对采用新的骨再生方法最有影响力。

结论

总之,本研究通过网络调查进行,突出了一个巨大的转化差距。它强调了外科医生和科学家之间进行有意义的跨学科合作的迫切需要(“行动呼吁”),这通常被称为“言行一致”的需要。这些发现强调了协调临床需求、研究成果和监管框架的重要性,以改善基于生物材料的骨移植物替代品的开发和实施,这些替代品在骨缺损治疗中具有疗效和效率。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7d89/11542434/654330115869/12916_2024_3734_Fig1_HTML.jpg

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