Wilson Nathaniel M, Moen Matthew T, Shaw Jordan T, Graf Ryan M, Behlmer Richard J, Simske Natasha M, Zirkle Lewis G, Whiting Paul S
Department of Orthopedics and Rehabilitation, University of Wisconsin School of Medicine and Public Health, Madison, WI.
SIGN Fracture Care International, Richland, WA.
OTA Int. 2020 Aug 5;3(3):e086. doi: 10.1097/OI9.0000000000000086. eCollection 2020 Sep.
The Surgical Implant Generation Network (SIGN) intramedullary nail was designed for use in resource limited settings which often lack fluoroscopy, specialized fracture tables, and power reaming. A newer design iteration, the SIGN Fin nail, was developed to further simplify retrograde femoral nailing by making proximal interlocking screw placement unnecessary. Instead, the leading end of the Fin nail achieves stability through an interference fit within the proximal femoral canal. While the performance of the traditional SIGN nail has been reported previously, no large series has examined long-term clinical and radiographic outcomes of femoral shaft fractures treated with the SIGN Fin nail.
The SIGN online surgical database was used to identify all adult femoral shaft fractures treated with the SIGN Fin nail since its introduction. All patients with minimum 6 month clinical and radiographic follow-up were included in the analysis. Available demographic, injury, and surgical characteristics were recorded. Fracture alignment was evaluated on final follow-up radiographs using a previously validated on-screen protractor tool. Coronal and sagittal plane alignment measurements were recorded as deviation from anatomic alignment (DFAA), with units in degrees. Fracture healing was assessed on final follow-up radiographs, with union defined as any bridging callus and/or cortical remodeling across one cortex on orthogonal views. Clinical outcomes available in the database included knee range of motion (ROM) greater than 90° and weight-bearing status at final follow-up. Clinical and radiographic outcomes were then compared between patients with united and nonunited fractures.
The database query identified 249 femoral shaft fractures stabilized with the Fin nail in 242 patients who had minimum 6 month clinical and radiographic follow-up. Final follow-up radiographs were performed at an average of 48 weeks postoperatively. Average coronal and sagittal plane alignment measured on final follow-up radiographs were 2.18° and 2.58°, respectively. The rate of malalignment (DFAA > 10° in either plane) at final follow-up was 6%. Two hundred twenty-nine fractures (92%) were united at final follow-up. Overall, 209 (84%) of patients achieved full weight bearing and 214 (86%) achieved knee ROM >90° at final follow-up. Compared to patients with united fractures, those with nonunion were less likely to achieve full weight bearing (20% vs 90%, < .001) and knee ROM >90° (30% vs 91%, < .001). There was no significant difference in mean DFAA between united and nonunited fractures in the coronal (2.1° vs 3.8°, = .298) or sagittal (2.5° vs 3.5°, = .528) planes.
The SIGN Fin nail achieves satisfactory radiographic alignment and clinical outcomes at minimum 6 month follow-up. The overall union rate is comparable to that achieved with the standard SIGN nail. Ease of implantation makes the Fin nail an attractive option in resource-limited settings.
外科植入物生成网络(SIGN)髓内钉专为资源有限的环境设计,这类环境通常缺乏透视设备、专用骨折手术台和动力扩髓设备。一种更新的设计版本,即SIGN鳍状钉,通过无需近端交锁螺钉置入进一步简化了逆行股骨钉固定术。相反,鳍状钉的前端通过与股骨近端髓腔的过盈配合实现稳定。虽然传统SIGN钉的性能此前已有报道,但尚无大型系列研究探讨使用SIGN鳍状钉治疗股骨干骨折的长期临床和影像学结果。
使用SIGN在线手术数据库识别自SIGN鳍状钉引入以来所有接受该钉治疗的成人股骨干骨折。所有具有至少6个月临床和影像学随访的患者纳入分析。记录可用的人口统计学、损伤和手术特征。使用先前验证的屏幕量角器工具在最终随访X线片上评估骨折对线情况。冠状面和矢状面的对线测量记录为与解剖对线的偏差(DFAA),单位为度。在最终随访X线片上评估骨折愈合情况,愈合定义为在正交视图上一侧皮质出现任何骨痂桥接和/或皮质重塑。数据库中可用的临床结果包括最终随访时膝关节活动范围(ROM)大于90°和负重状态。然后比较骨折愈合和未愈合患者的临床和影像学结果。
数据库查询识别出242例接受鳍状钉固定的股骨干骨折患者,这些患者均有至少6个月的临床和影像学随访。最终随访X线片平均在术后48周进行。最终随访X线片上测得的平均冠状面和矢状面对线分别为2.18°和2.58°。最终随访时对线不良(任一平面DFAA>10°)的发生率为6%。229例骨折(92%)在最终随访时愈合。总体而言,209例(84%)患者在最终随访时实现完全负重,214例(占86%)患者在最终随访时膝关节ROM>90°。与骨折愈合的患者相比,未愈合患者实现完全负重(20%对90%,<0.001)和膝关节ROM>90°(30%对91%,<0.001)的可能性较小。骨折愈合和未愈合患者在冠状面(2.1°对3.8°,P = 0.298)或矢状面(2.5°对3.5°,P = 0.528)的平均DFAA无显著差异。
SIGN鳍状钉在至少6个月的随访中获得了令人满意的影像学对线和临床结果。总体愈合率与标准SIGN钉相当。易于植入使鳍状钉在资源有限的环境中成为一个有吸引力的选择。