Yang Kun, Yang Yunkang, Ge Jianhua, Bai Rui, Xiang Feifan, Sun Yuanlin, Zhou Ju
Department of Bone and Joint Surgery, Affiliated Hospital of Southwest Medical University, Luzhou Sichuan, 646000, P.R.China.
Department of Bone and Joint Surgery, Affiliated Hospital of Southwest Medical University, Luzhou Sichuan, 646000,
Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi. 2017 Apr 15;31(4):392-396. doi: 10.7507/1002-1892.201611123.
To develop a new type of tail cap for closing the tail of the central hole of the interlocking intramedullary nail so as to reduce difficulty in implantation of the tail cap into intramedullary nail, and ensure the accuracy of implantation, as well as reduce unnecessary operation time.
In 2014, the new type of intramedullary nail tail cap ("new tail cap" for short) was successfully developed, and has been granted national utility model patent. A randomized controlled clinical trial was conducted in 34 patients with non pathological femoral shaft fractures treated between August 2014 and March 2016. The patients were randomly divided into groups A and B, 17 patients each group. There was no significant difference in gender, age, side, body mass index, cause of injury, injury to operation time, and fracture AO classification between groups ( >0.05), with comparability. All patients underwent fixation with interlocking intramedullary nail, and the new tail cap and original tail cap were used in groups A and B respectively. The blood loss and operation time during tail cap implantation, fracture healing time, and complications were recorded and compared between 2 groups; the limb function was evaluated by Klemm function evaluation standard.
The blood loss and operation time during tail cap implantation of group A [(3.5±0.8) mL and (10.57±3.15) s] were significantly less than those of group B [(5.5±1.7) mL and (21.99±6.90) s] ( =-8.281, =0.010; =-10.743, =0.009). All new tail caps were successfully implanted by one-time in group A, and the one-time success rate was 100%; the original tail cap exfoliation occurred in 3 cases of group B, and the one-time success rate was 82.4%. All the patients were followed up 6-16 months (mean, 9.7 months); there was no deep infection, loosening or breakage of internal fixation, and other serious complications. The time of fracture healing was (16.4±3.2) weeks in group A and (15.8±3.5) weeks in group B, showing no significant difference ( =0.514, 0.611). At last follow-up, according to the Klemm function evaluation standard, the results were excellent in 14 cases and good in 3 cases in group A, and were excellent in 11 cases and good in 6 cases in group B, showing no significant difference between 2 groups ( =0.142, =0.707).
The new type of femoral intramedullary nail tail cap can simplify operation, shorten operation time, and reduce blood loss, and it has satisfactory effectiveness.
研制一种新型尾帽用于闭合交锁髓内钉中央孔尾部，以降低尾帽植入髓内钉的难度，确保植入准确性，并减少不必要的手术时间。
2014年成功研制出新型髓内钉尾帽（简称“新尾帽”），并已获国家实用新型专利。对2014年8月至2016年3月收治的34例非病理性股骨干骨折患者进行随机对照临床试验。患者随机分为A、B组，每组17例。两组在性别、年龄、患侧、体重指数、受伤原因、受伤至手术时间及骨折AO分型等方面差异无统计学意义（P>0.05），具有可比性。所有患者均采用交锁髓内钉固定，A组使用新尾帽，B组使用原尾帽。记录并比较两组尾帽植入时的出血量、手术时间、骨折愈合时间及并发症；采用Klemm功能评价标准评估肢体功能。
A组尾帽植入时的出血量[（3.5±0.8）mL]及手术时间[（10.57±3.15）s]明显少于B组[（5.5±1.7）mL及（21.99±6.90）s]（t=-8.281，P=0.010；t=-10.743，P=0.009）。A组所有新尾帽均一次性成功植入，一次性成功率为100%；B组有3例原尾帽脱落，一次性成功率为82.4%。所有患者均获随访6~16个月（平均9.7个月）；未出现深部感染、内固定松动或断裂等严重并发症。A组骨折愈合时间为（16.4±3.2）周，B组为（15.8±3.5）周，差异无统计学意义（t=0.514，P=0.611）。末次随访时，根据Klemm功能评价标准，A组优14例，良3例；B组优11例，良6例，两组差异无统计学意义（z=0.142，P=0.707）。
新型股骨髓内钉尾帽可简化手术、缩短手术时间、减少出血量，效果满意。
