Department of Orthopaedics, Patras University Hospital, Medical School, Patras University, Papanikolaou 1, 26504, Rio-Patras, Greece.
Laboratory of Technology and Strength of Materials, Department of Mechanical Engineering and Aeronautics, University of Patras, Patras, Greece.
J Orthop Surg Res. 2023 Jul 28;18(1):542. doi: 10.1186/s13018-023-04009-8.
Hip fractures are an increasingly common consequence of falls in older people that are associated with a high risk of death and reduced function. The vast majority of intertrochanteric fractures require surgical treatment to withstand early mobilization and weight bearing, which prevents complications due to prolonged bed rest and aids in fracture healing.
This study is compromised by two parts, the experimental study and the clinical part. In the first part, a standard 130° nail will be used with the appropriate lag screw(s) and dynamic distal locking in synthetic osteoporotic femurs and the transmission of forces in the proximal femur, measured by a cortical surface-strain distribution, will be evaluated using digital image correlation. Finite element parametric models of the bone, the nails and their interface will be also developed. Finite element computations of surface strains in implanted femurs, after being validated against biomechanical testing measurements, will be used to assist the comparison of the nails by deriving important data on the developed stress and strain fields, which cannot be measured through biomechanical testing. In the other part, will set up a prospective, randomized, comparative clinical study among the Gamma3 and IT cephalomedullary nailing, in order to investigate if there are any statistical important differences in the main radiological measurements and functional status in closed unstable intertrochanteric fractures (A21-3) in patients aged over 70 years old at the 24-week follow-up evaluation using patient reported disease-specific outcomes.
This study will be the first to compare clinical, radiological and biomechanical measurements of the two different cephalomedullary nails. Our main hypothesis is that the IT nail would provide better radiological outcome and probably better clinical results than the Gama3 nail. Clinical trial registration International Standard Randomized Controlled Trial Number (ISRCTN): https://doi.org/10.1186/ISRCTN15588442 , registered on 19/4/2022.
髋部骨折是老年人跌倒的常见后果，与高死亡率和功能下降有关。绝大多数股骨转子间骨折需要手术治疗，以承受早期活动和负重，防止因长时间卧床休息引起的并发症，并有助于骨折愈合。
本研究由两部分组成，实验研究和临床部分。在第一部分中，将使用标准的 130°钉和适当的拉力螺钉（s）以及动态远端锁定在合成骨质疏松股骨中，并通过皮质表面应变分布测量力在股骨近端的传递，使用数字图像相关进行评估。还将开发骨骼、钉和其界面的有限元参数模型。经过生物力学测试测量验证后，对植入股骨表面应变的有限元计算将用于辅助通过得出无法通过生物力学测试测量的重要的应力和应变场数据来比较钉，从而对钉进行比较。在另一部分中，将在 Gamma3 和 IT 股骨近端髓内钉之间建立一项前瞻性、随机、对照的临床研究，以调查在 70 岁以上的患者中，闭合性不稳定股骨转子间骨折（A21-3）的 24 周随访评估中，主要影像学测量和功能状态是否存在任何统计学上的显著差异，使用患者报告的疾病特异性结局。
本研究将首次比较两种不同的股骨近端髓内钉的临床、放射学和生物力学测量。我们的主要假设是 IT 钉在放射学结果和临床结果方面都优于 Gamma3 钉。临床试验注册国际标准随机对照试验编号（ISRCTN）：https://doi.org/10.1186/ISRCTN15588442，于 2022 年 4 月 19 日注册。
