股骨干骨折闭合复位器及髓内钉进针瞄准器的研制与临床应用  

Design and clinical application of a reduction and nailing-guide instrument in closed reduction andinternal fixation of femoral shaft fracture with intramedullary nails

作　　者：徐海涛[1] 盛加根[1] 陆男吉[1] 周祖彬[1] 宋飒[1] 安智全[1] 

机构地区：[1]上海交通大学附属第六人民医院骨科,200233

出　　处：《中华创伤骨科杂志》2014年第2期104-109,共6页Chinese Journal of Orthopaedic Trauma

基　　金：上海市卫生局课题（2007040）

摘　　要：目的自行设计并研制辅助股骨干骨折闭合复位及髓内钉进针的器械，探讨其I临床应用效果。方法采用前瞻性随机对照研究方法，将2011年12月至2013年1月收治且符合病例纳入标准的44例股骨干骨折患者随机分为2组：试验组22例，男16例，女6例；平均年龄为（33．1±8．O）岁；术中使用自行设计并研制的股骨干骨折闭合复位器及髓内钉进针瞄准器。对照组22例，男13例，女9例；平均年龄为（34．0±9．1）岁；术中不使用复位器及瞄准器。所有患者均行闭合复位顺行交锁髓内钉内固定术。比较两组患者的手术时间、术中出血量、进针点穿针次数、导针进入骨折远端的穿针次数、需要小切口辅助复位的患者例数及骨折愈合时间等。结果44例患者术后获8-20个月（平均l1．8个月）随访。除对照组1例发生骨不连行再次手术植骨外，其余患者无感染等其他并发症发生。试验组患者的手术时间[（71．7±5．5）min]短于对照组[（81．0±4．7）rain]，进针点穿针次数（1次）、导针进入骨折远端的穿针次数（1次）、需要小切口辅助复位的患者例数（0）均少于对照组（3次、4次、8例），两组比较差异有统计学意义（P〈0．05）。两组患者的术中出血量及骨折愈合时间比较差异均无统计学意义（P〉0．05）。结论股骨干骨折闭合复位器及髓内钉进针瞄准器操作方便，对常规闭合复位困难的股骨干骨折能很好地辅助复位，且能有效辅助髓内钉进针，临床应用价值较高。Objective To evaluate an instrument that we have designed to assist closed reduction and intramedullary nailing for femoral shaft fractures. Methods We conducted a prospective randomized controlled trial to validate the clinical efficacy of the instrument we designed and manufactured. From De- cember 2011 to January 2013, 44 eligible cases of femoral shaft fracture were randomized into an experiment group and a control group. The self-designed reduction and nailing-guide instrument was used in the experi- mental group which consisted of 16 males and 6 females with a mean age of 33.1±8.0 years. The control group, which consisted of 13 males and 9 females with a mean age of 34.0±9. 1 years, did not use the in- strument. Both groups received closed reduction and internal fixation with anterograde interlocking in- tramedullary nail. The operation time, bleeding volume, frequency of insertion, frequency of nailing into the distal fracture end, number of additional small incision for open reduction, union time, and complications were recorded and compared between the 2 groups. Results The 44 cases were followed up for 8 to 20 months （average, 11.8 months） . All patients attained fracture union except one case of non-union in the control group who had to undergo reoperation. No infection or other complications occurred. Compared with the control group, the experimental group had significantly less operation time （71.7±5.5 minutes versus 81.0 ±4.7 minutes）, fewer frequency of insertion （ 1 versus 3）, fewer frequency of nailing into the distal fracturt end （ 1 versus 4）, and smaller number of additional small incision for open reduction （0 versus 8） （ P 〈 0.05）. There were no statistically significant differences in the bleeding volume or union time between the 2 groups （ P 〉 0.05） . Conclusion The instrument we have designed is simple, easy to use, and effective in assisting closed reduction and intramedullary nailing for femoral shaft fractures.

关 键 词：股骨骨折 骨折固定术 髓内 骨钉 外科器械 

分 类 号：R687.1[医药卫生—骨科学]