Schmitz Peter P, Hannink Gerjon, Reijmer Joey, Somford Matthijs P, Van Susante Job L C
Department of Orthopedics, Rijnstate Hospital, Arnhem.
Department of Operating Rooms, Radboud University Medical Center Nijmegen, Nijmegen, The Netherlands.
Acta Orthop. 2022 Jan 11;93:234-240. doi: 10.2340/17453674.2022.1410.
Background and purpose - Trochanteric fractures are often treated using intramedullary fixation. In our institution, the TFN-Advanced Proximal Femoral Nailing System (TFNA) was introduced as replacement for the Gamma Trochanteric Nail (GTN3) for the treatment of these fractures as a result of a hospital-driven change of trauma implant supplier. We compared trochanteric fracture fixation failure rate between these 2 intramedullary nails. Patients and methods - All trochanteric fractures treated surgically from 2011 to 2019 were retrospectively reviewed for fixation failure. From 2016 only the TFNA was used. Fixation failure was defined as implant cut-out, implant breakage, non-union, malpositioning of the screw/blade requiring reoperation, new fracture around the nail, or miscellaneous. Propensity score matching was used to balance distribution of covariates and to compare failure rates between TFNA and GTN3 groups. Learning curve analyses were performed. Results - After exclusion, 797 GTN3s (779 patients) and 542 (536 patients) TFNAs were available for analysis. A higher risk of fixation failure was found in the TFNA group (14%) compared with the GTN3 group (7.0%) (hazard ratio [HR] 2.0, 95% confidence interval [CI] 1.2-3.5). This was mainly attributed to a higher risk of cut-out (HR 2.2; CI 0.9-5.7), malpositioning (HR 4.7; CI 0.7-34), and new fracture around the nail (HR 4.0; CI 1.0-16). Learning curve analyses indicated no clear learning curve effect. Interpretation - Failure of fixation increased after a switch from the GTN3 to the TFNA proximal femoral nail for the treatment of trochanteric fractures. Cut-out and malpositioning of the calcar screw or blade appeared to be the most dominant failure mechanisms. Modifications in implant design may have played a role in this increased risk of failure of fixation. In our institution a new implant device was introduced without solid clinical evidence behind it. This study may help to underline the need for medical doctors with a critical and scientific background to be involved in implant choices.
背景与目的——转子间骨折常采用髓内固定治疗。在我们机构，由于医院主导的创伤植入物供应商变更，引入了TFN-Advanced近端股骨钉系统（TFNA）来替代Gamma转子钉（GTN3）治疗这些骨折。我们比较了这两种髓内钉治疗转子间骨折的固定失败率。
患者与方法——回顾性分析2011年至2019年所有接受手术治疗的转子间骨折的固定失败情况。从2016年起仅使用TFNA。固定失败定义为植入物穿出、植入物断裂、骨不连、螺钉/刀片位置不当需再次手术、钉子周围新发骨折或其他情况。采用倾向评分匹配来平衡协变量分布，并比较TFNA组和GTN3组的失败率。进行了学习曲线分析。
结果——排除后，797枚GTN3（779例患者）和542枚（536例患者）TFNA可用于分析。与GTN3组（7.0%）相比，TFNA组（14%）固定失败风险更高（风险比[HR]2.0，95%置信区间[CI]1.2 - 3.5）。这主要归因于穿出风险更高（HR 2.2；CI 0.9 - 5.7）、位置不当（HR 4.7；CI 0.7 - 34）以及钉子周围新发骨折（HR 4.0；CI 1.0 - 16）。学习曲线分析表明无明显的学习曲线效应。
解读——从GTN3转换为TFNA近端股骨钉治疗转子间骨折后，固定失败增加。股骨距螺钉或刀片的穿出和位置不当似乎是最主要的失败机制。植入物设计的改变可能在这种固定失败风险增加中起了作用。在我们机构，一种新的植入装置在没有坚实临床证据的情况下被引入。本研究可能有助于强调具有批判性和科学背景的医生参与植入物选择的必要性。
