Design And Clinical Application Of A Reduction And Pin-Aiming Instrument For Closed Reduction And Internal Fixation Of Intramedullary Nail In Femoral Shaft Fracture

Objective To design an instrument that could assist in closed reduction and nailing during the operation of femoral shaft fractures, and to validate its effect via clinical appliance.Methods We designed and manufactured an original instrument and conducted prospective randomized controlled trial to validate its clinical effect.44cases of femoral shaft fracture were equally assigned into experiment group and control group randomly between December2011and January2013, with29males and15females, at a mean age of33.5years (range,18-59years). Following AO classification, there were10AO Type A,27Type B and7Type C fractures. The instrument was used during the operation in the experiment group while only normal intramedullary nail was used in the control group. The operation time, the bleeding volume, the frequency of pinning, the case number of additional small incision for open reduction, the union time and postoperative complications were recorded and compared between the two groups.Results The follow-up of the44cases ranged from8to20months (average,11.8months), and all patients attained fracture union except one case of non-union in control group, who had to ungergo reoperation. No infection or other complications occurred. There were no statistically significant differences in the bleeding volume and the union time between the two groups (P≥0.05). The operation time, the frequency of pinning, and the case number of open reduction were significantly smaller in experiment group than those in control group(P<0.05).Conclusions Femoral shaft fractures are not easy to be reduced by general methods in certain cases. The instrument, which is simple and easy to use, showed high clinical value and proved effective in assisting in the closed reduction and nailing.