Computer Assisted Radiology & Surgery, University Hospital Basel, Realpstrasse 54, CH-4057 Basel, Switzerland.
Injury. 2010 Apr;41(4):388-95. doi: 10.1016/j.injury.2009.10.021. Epub 2009 Nov 8.
The utilisation and consequences of standardised operative procedures may importantly differ between different healthcare systems. This is the first investigation comparing the treatment and outcome of femoral shaft fractures stabilised with an identical implant between trauma centres in 2 continents (Europe, EU and South Africa, SA).
Following standardised introduction of the technique, the prospective, observational multicentre study enrolled 175 patients who underwent intramedullary fracture fixation using the antegrade femoral nail (AFN) for femoral shaft fractures. Eleven EU hospitals recruited 86 patients and 1 SA centre 89 patients in the study period. Comparison of epidemiologic data, operative characteristics as well as subjective (e.g., pain, SF-36) and objective (e.g., X-ray, range of motion [ROM]) 3-month and 1-year outcomes were performed (p<0.05).
Compared to EU centres, several significant differences were observed in SA: (1) on average, patients operated on were younger, had less concomitant diseases and had more severe open fractures; (2) operative stabilisation was more often undertaken by young, unsupervised residents, with shorter operating and intraoperative fluoroscopy times; (3) mean hospital stay was shorter, with less recorded complications, but a higher loss to follow-up rate. Non- or malunion rates and subjective outcomes were similar for both groups, with the physical component of the SF-36 at the 1-year follow-up not fully restoring to baseline values.
Our investigation demonstrates the importance of several major differences between 2 different regions of the world in the treatment of femoral shaft fractures, despite involving only high level trauma centres and using an identical implant. The intercontinental comparison of results from clinical studies should be interpreted very carefully considering the heterogeneity of populations and clinical settings.
标准化手术操作的使用和结果在不同的医疗体系中可能有很大的不同。这是首次比较两个大洲（欧洲，欧盟和南非）的创伤中心使用相同的植入物治疗股骨干骨折的治疗和结果。
在标准化技术引入后，前瞻性、观察性多中心研究纳入了 175 例使用顺行股骨髓内钉（AFN）治疗股骨干骨折的患者。研究期间，11 家欧盟医院招募了 86 例患者，1 家南非医院招募了 89 例患者。比较了流行病学数据、手术特点以及主观（如疼痛、SF-36）和客观（如 X 射线、关节活动度 [ROM]）的 3 个月和 1 年结果（p<0.05）。
与欧盟中心相比，南非中心存在几个显著差异：（1）平均而言，手术患者年龄更小，合并症更少，开放性骨折更严重；（2）手术稳定性更多地由年轻、无监督的住院医师进行，手术和术中透视时间更短；（3）平均住院时间更短，记录的并发症更少，但失访率更高。两组的非愈合或畸形愈合率和主观结果相似，SF-36 的物理成分在 1 年随访时仍未完全恢复到基线值。
我们的研究表明，尽管涉及的只是高水平的创伤中心，并使用相同的植入物，两个不同地区的股骨干骨折治疗存在几个重要的差异。在解释来自临床研究的结果时，应该非常小心地考虑人群和临床环境的异质性。
