Viberg Bjarke, Rasmussen Katrine M V, Overgaard Søren, Rogmark Cecilia
a Department of Orthopedic Surgery and Traumatology , Odense University Hospital , Odense.
b Department of Clinical Research , University of Southern Denmark , Odense , Denmark.
Acta Orthop. 2017 Aug;88(4):427-433. doi: 10.1080/17453674.2017.1304207. Epub 2017 Mar 13.
Background and purpose - The proximal femur locking compression plate (PF-LCP) is a new concept in the treatment of hip fractures. When releasing new implants onto the market, biomechanical studies are conducted to evaluate performance of the implant. We investigated the relation between biomechanical and clinical studies on PF-LCP. Methods - A systematic literature search of relevant biomechanical and clinical studies was conducted in PubMed on December 1, 2015. 7 biomechanical studies and 15 clinical studies were included. Results - Even though the biomechanical studies showed equivalent or higher failure loads for femoral neck fracture, the clinical results were far worse, with a 37% complication rate. There were no biomechanical studies on pertrochanteric fractures. Biomechanical studies on subtrochanteric fractures showed that PF-LCP had a lower failure load than with proximal femoral nail, but higher than with angled blade plate. 4 clinical studies had complication rates less than 8% and 9 studies had complication rates between 15% and 53%. Interpretation - There was no clear relation between biomechanical and clinical studies. Biomechanical studies are generally inherently different from clinical studies, as they examine the best possible theoretical use of the implant without considering the long-term outcome in a clinical setting. Properly designed clinical studies are mandatory when introducing new implants, and they cannot be replaced by biomechanical studies.
背景与目的——股骨近端锁定加压钢板(PF-LCP)是治疗髋部骨折的一个新概念。在将新植入物投放市场时,会进行生物力学研究以评估植入物的性能。我们研究了PF-LCP生物力学研究与临床研究之间的关系。方法——2015年12月1日在PubMed上对相关生物力学和临床研究进行了系统的文献检索。纳入了7项生物力学研究和15项临床研究。结果——尽管生物力学研究表明股骨颈骨折的失效载荷相当或更高,但临床结果却差得多,并发症发生率为37%。没有关于转子间骨折的生物力学研究。转子下骨折的生物力学研究表明,PF-LCP的失效载荷低于股骨近端髓内钉,但高于角钢板。4项临床研究的并发症发生率低于8%,9项临床研究的并发症发生率在15%至53%之间。解读——生物力学研究与临床研究之间没有明确的关系。生物力学研究通常本质上与临床研究不同,因为它们研究的是植入物在理论上的最佳使用情况,而不考虑临床环境中的长期结果。在引入新植入物时,必须进行设计合理的临床研究,且它们不能被生物力学研究所取代。