Development and clinical application of a new type of intramedullary nail tail cap

Abstract

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 ( P>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] ( t=-8.281, P=0.010; t=-10.743, P=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 ( t=0.514, P=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 ( χ2=0.142, P=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.