University of Washington School of Medicine, Seattle, WA, USA.
Department of Orthopedics, OHSU, 3147 S.W. Sam Jackson Park Road, Portland, OR, 97239, USA.
Int Orthop. 2019 Feb;43(2):433-440. doi: 10.1007/s00264-018-3966-z. Epub 2018 May 28.
Since its development in 1999, the SIGN nail has been used in over 190,000 surgeries spanning 55 countries. To date, however, evaluation of SIGN nail outcomes has been limited to small prospective studies or large retrospective studies using SIGN's online database. This study uses the experience of a single, independent Cambodian surgical clinic to characterize common complications, provide commentary on ways to reduce the risk of those complications, and determine whether several observed nail fractures were due to metallurgic defects.
Clinic medical records were queried to identify complications in patients with SIGN nails. Data was abstracted including age, sex, mechanism of injury, and latency between injury, primary implantation, and presentation with a complication. Two nails that fractured in vivo were analyzed by light microscopy, scanning electron microscopy, and polarized light microscopy after chemical etching.
Fifty-four complications in 51 patients were identified. The most common complications were non-union (n = 26, 48%), infection (n = 16, 30%), flexion limitation (n = 11, 20%), nail fracture (n = 4, 7%), delayed union (n = 4, 7%), and malunion (n = 4, 7%). Other complications included broken or floating screws. Fractography revealed that two of the fractured nails most likely failed by fatigue followed by fast fracture at the site of non-union. We found no evidence of intrinsic nail defects. We identified multiple inconsistencies between SIGN's database and independent clinic records.
Non-union and infection were common relative to all complications. Based on radiographic review, risk for non-union and malunion can be minimized by selecting an appropriate nail diameter, using multiple interlocking screws, and employing the correct implant and approach for fracture morphology when using SIGN nails. Nail fractures were unlikely to be caused by metallurgical flaws. Further study is necessary to determine the appropriate management of non-unions based on radiographic and clinical factors.
自 1999 年开发以来,SIGN 钉已在 55 个国家的超过 190,000 例手术中使用。然而,迄今为止,对 SIGN 钉结果的评估仅限于小型前瞻性研究或使用 SIGN 在线数据库的大型回顾性研究。本研究利用一家独立的柬埔寨外科诊所的经验,对常见并发症进行特征描述,提供降低这些并发症风险的方法,并确定观察到的几例钉断裂是否是由于冶金缺陷造成的。
对 SIGN 钉患者的并发症进行诊所病历查询。提取的数据包括年龄、性别、损伤机制以及损伤、初次植入和出现并发症之间的潜伏期。对体内断裂的两根钉进行了光镜、扫描电镜和化学蚀刻后的偏光显微镜分析。
在 51 名患者中发现了 54 种并发症。最常见的并发症是非愈合(n=26,48%)、感染(n=16,30%)、活动度受限(n=11,20%)、钉断裂(n=4,7%)、延迟愈合(n=4,7%)和畸形愈合(n=4,7%)。其他并发症包括螺钉断裂或松动。断口分析显示,其中两根断裂的钉最有可能因疲劳而失效,随后在非愈合处快速断裂。我们没有发现内在钉缺陷的证据。我们发现 SIGN 数据库和独立诊所记录之间存在多个不一致之处。
与所有并发症相比,非愈合和感染更为常见。根据影像学复查结果,通过选择合适的钉直径、使用多个锁定螺钉,以及根据骨折形态选择正确的植入物和入路,可将非愈合和畸形愈合的风险降到最低。钉断裂不太可能是由冶金缺陷引起的。需要进一步研究,根据影像学和临床因素确定非愈合的适当治疗方法。