CAJ | 학술논문

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±8.0)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11.8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)min],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.
목적 자행설계병연제보조고골간골절폐합복위급수내정진침적기계,탐토기림상응용효과.방법 채용전첨성수궤대조연구방법,장2011년12월지2013년1월수치차부합병례납입표준적44례고골간골절환자수궤분위2조:시험조22례,남16례,녀6례;평균년령위(33.1±8.0)세;술중사용자행설계병연제적고골간골절폐합복위기급수내정진침묘준기.대조조22례,남13례,녀9례;평균년령위(34.0±9.1)세;술중불사용복위기급묘준기.소유환자균행폐합복위순행교쇄수내정내고정술.비교량조환자적수술시간、술중출혈량、진침점천침차수、도침진입골절원단적천침차수、수요소절구보조복위적환자례수급골절유합시간등. 결과 44례환자술후획8 ～ 20개월(평균11.8개월)수방.제대조조1례발생골불련행재차수술식골외,기여환자무감염등기타병발증발생.시험조환자적수술시간[(71.7±5.5)min]단우대조조[(81.0±4.7)min],진침점천침차수(1차)、도침진입골절원단적천침차수(1차)、수요소절구보조복위적환자례수(0)균소우대조조(3차、4차、8례),량조비교차이유통계학의의(P＜0.05).량조환자적술중출혈량급골절유합시간비교차이균무통계학의의(P＞0.05). 결론 고골간골절폐합복위기급수내정진침묘준기조작방편,대상규폐합복위곤난적고골간골절능흔호지보조복위,차능유효보조수내정진침,림상응용개치교고.
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 December 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 experimental 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 instrument.Both groups received closed reduction and internal fixation with anterograde interlocking intramedullary 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 fracture 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.