Abstract
Background: Aseptic nonunion of femoral shafts after intramedullary nailing (IMN) can be a challenging condition that may lead to long-term disability and the need for multiple surgical procedures. This study compared the clinical and radiological outcomes between exchange nailing and augmentative plating with bone grafting. Methods: In this multicenter, prospective, single-blind, randomized controlled trial, patients with aseptic nonunion of the femoral shaft after IMN were randomly assigned to receive exchange nailing or augmentative plating. The primary outcomes measured were the time to bone union and union rate 12 months after revision surgery. The secondary outcomes included operative time, blood loss, hospitalization duration, pain level using the visual analog scale (VAS), knee range of motion (ROM), and complication rates. Results: The augmentative plating group had a significantly shorter mean time to union (5.39 ± 1.29 months) compared with the exchange nailing group (7.38 ± 1.97 months; p < 0.001). The union rates at 12 months were 100% in the augmentative plating group and 89.65% in the exchange nail group. Augmentative plating resulted in a shorter operation time (99.46 ± 11.08 min vs. 106.45 ± 12.22 min; p = 0.025) and reduced blood loss (514.79 ± 45.87 mL vs. 547.72 ± 54.35 mL; p = 0.016). Significant pain reduction was observed in the augmentative plating group, with preoperative VAS scores decreasing from 6.04 ± 2.28 to 2.64 ± 1.50, compared with a decrease from 5.66 ± 2.21 to 3.66 ± 2.19 in the exchange nailing group (p = 0.047). Knee ROM improved significantly in the augmentative plating group (p = 0.0176). The complication rate was lower in the augmentative plating group (3.57%) than in the exchange nail group (17.24%). Conclusions: Augmentative plating with autologous bone grafting is superior to exchange nailing for treating aseptic nonunion of femoral shafts. It is associated with faster healing, higher union rates, better clinical and functional outcomes, and fewer complications. We recommend this technique as the preferred treatment option for such complex cases.