Carsen Sasha, Park Sam Si-Hyeong, Simon David A, Feibel Robert J
Division of Orthopaedic Surgery, University of Ottawa, Ottawa, ON, K1H 8L6, Canada,
Clin Orthop Relat Res. 2015 Jul;473(7):2394-401. doi: 10.1007/s11999-015-4290-1. Epub 2015 Apr 17.
The burden of orthopaedic trauma in the developing world is substantial and disproportionate. SIGN Fracture Care International is a nonprofit organization that has developed and made available to surgeons in resource-limited settings an intramedullary interlocking nail for use in the treatment of femoral and tibial fractures. Instrumentation also is donated with the nail. A prospectively populated database collects information on all procedures performed using this nail. Given the challenging settings and numerous surgeons with varied experience, it is important to document adequate alignment and union using the device.
QUESTIONS/PURPOSES: The primary aim of this research was to assess the adequacy of operative reduction of closed diaphyseal femur fractures using the SIGN interlocking intramedullary nail based on radiographic images available in the SIGN database. The secondary aims were to assess correlations between postoperative alignment and several associated variables, including fracture location in the diaphysis, degree of fracture site comminution, and time to surgery. The tertiary aim was to assess the functionality of the SIGN database for radiographic analyses.
A review of the prospectively populated SIGN database was performed for patients with a diaphyseal femur fracture treated with the SIGN nail, which at the time of the study totaled 32,362 patients. After study size calculations, a random number generator was used to select 500 femur fractures for analysis. Exclusion criteria included open fractures and those without radiographs during the early postoperative period. The following information was recorded: location of the fracture in the diaphysis; fracture classification (AO/Orthopaedic Trauma Association [OTA] classification); degree of comminution (Winquist and Hansen classification); time from injury to surgery; and patient demographics. Measurements of alignment were obtained from the AP and lateral radiographs with malalignment defined as deformity in either the sagittal or coronal plane greater than 5°. Measurements were made manually by the four study authors using on-screen protractor software and interobserver reliability was assessed.
The frequency of malalignment greater than 5° observed on postoperative radiographs was 51 of 501 (10%; 95% CI, 6.5-11.5), and malalignment greater than 10° occurred in eight of 501 (1.6%) of the femurs treated with this nail. Fracture location in the proximal or distal diaphysis was strongly correlated with risk of malalignment, with an odds ratio (OR) of 3.7 (95% CI, 1.5-9.3) for distal versus middle diaphyseal fractures and an OR of 4.7 (95% CI, 1.9-11.5) for proximal versus middle fractures (p < 0.001). Time from injury to surgery greater than 4 weeks also was strongly correlated with risk of malalignment (p < 0.001). Inherent fracture stability, based on fracture site comminution as per the Winquist and Hansen classification (Class 0-1 stable versus 2-4 unstable) showed an OR of 2.3 (95% CI, 1.2-4.3) for malalignment in unstable fractures. Interobserver reliability showed agreement of 88% (95% CI, 83-93) and mean kappa of 0.81 (95% CI, 0.65-0.87). The SIGN database of radiographic images was found to be an excellent source for research purposes with 92% of reviewed radiographs of acceptable quality.
The frequency of malalignment in closed diaphyseal femoral fractures treated with the SIGN nail closely approximated the incidence reported in the literature for North American trauma centers. Increased time from injury to surgery was correlated with increased frequency of malalignment; as humanitarian distribution of the SIGN nail increases, local barriers to timely care should be assessed and improved as possible. Prospective clinical study with followup, despite its inherent challenges in the developing world, would be of great benefit in the future.
Level III, therapeutic study.
在发展中国家，骨科创伤的负担巨大且不成比例。国际骨折治疗组织（SIGN Fracture Care International）是一个非营利组织，它开发了一种髓内交锁钉，并将其提供给资源有限地区的外科医生，用于治疗股骨和胫骨骨折。该器械也随钉捐赠。一个前瞻性建立的数据库收集了所有使用这种钉子进行手术的信息。鉴于手术环境具有挑战性且外科医生经验各异，记录使用该器械实现的充分对线和骨折愈合情况很重要。
问题/目的：本研究的主要目的是根据SIGN数据库中的X线影像，评估使用SIGN交锁髓内钉治疗闭合性股骨干骨折时手术复位的充分性。次要目的是评估术后对线与几个相关变量之间的相关性，这些变量包括骨干骨折部位、骨折部位粉碎程度以及手术时间。第三个目的是评估SIGN数据库用于X线分析的功能。
对前瞻性建立的SIGN数据库进行回顾，纳入使用SIGN钉治疗股骨干骨折的患者，研究时共有32362例患者。在计算研究样本量后，使用随机数生成器选择500例股骨骨折进行分析。排除标准包括开放性骨折以及术后早期没有X线片的病例。记录以下信息：骨干骨折部位；骨折分类（AO/骨科创伤协会[OTA]分类）；粉碎程度（Winquist和Hansen分类）；受伤至手术的时间；以及患者人口统计学资料。从前后位和侧位X线片上获得对线测量值，对线不良定义为矢状面或冠状面畸形大于5°。四位研究作者使用屏幕量角器软件手动进行测量，并评估观察者间的可靠性。
术后X线片上观察到的对线不良大于5°的发生率为501例中的51例（10%；95%CI，6.5 - 11.5），使用该钉子治疗的股骨中，对线不良大于10°的发生率为501例中的8例（1.6%）。骨干近端或远端骨折部位与对线不良风险密切相关，远端与中段骨干骨折的比值比（OR）为3.7（95%CI，1.5 - 9.3），近端与中段骨折的OR为4.7（95%CI，1.9 - 11.5）（p < 0.001）。受伤至手术时间大于4周也与对线不良风险密切相关（p < 0.001）。根据Winquist和Hansen分类（0 - 1级稳定与2 - 4级不稳定），基于骨折部位粉碎情况的固有骨折稳定性显示，不稳定骨折的对线不良OR为2.3（95%CI，1.2 - 4.3）。观察者间可靠性显示一致性为88%（95%CI，83 - 93），平均kappa值为0.81（95%CI，0.65 - 0.87）。发现用于研究目的的SIGN X线影像数据库是一个很好的来源，92%的回顾X线片质量可接受。
使用SIGN钉治疗闭合性股骨干骨折时对线不良的发生率与北美创伤中心文献报道的发生率相近。受伤至手术时间延长与对线不良频率增加相关；随着SIGN钉的人道主义分发增加，应评估并尽可能改善及时治疗的当地障碍。尽管在发展中国家进行前瞻性临床随访研究存在固有挑战，但未来将大有裨益。
III级，治疗性研究。
