Functional outcome of patients of tibial fracture treated with solid nail (SIGN nail) versus conventional hollow nail - A randomized trial.

Background: Trauma related disabilities disproportionately affects low and middle income countries due to lack of resources, skills and optimal implants. Despite adequate animal studies, biomechanical studies, cohort studies and comparison studies we are not aware of any randomized trial to compare the functional outcome of SIGN (Surgical Implant Generation Network, US) solid nailing with a hollow nailing for tibial shaft fracture.

Methods: Sixty patients (≥16 years) of closed and Gustilo grade I traumatic fractures of the leg were randomized into SIGN solid nailing or hollow nailing group. Cases with compromised soft tissue and grossly deformed medullary canal were excluded. Functional outcome and need for resurgery were the primary outcomes while the secondary outcomes were duration of surgery, intraoperative blood loss, overall pain (VAS), radiological union (RUST), surgery related complications (infection, malalignment, shortening, nonunion) and pain/range of motion (ROM) of knee/ankle. All SIGN surgery related data were entered and retrieved online from www.signsurgery.org.

Result: The demographical parameters were symmetrically distributed between the groups (p > 0.05). 2 cases in SIGN nailing and 4 cases in hollow nailing needed open reduction. The functional outcome, as assessed by blinded physiotherapist using Johner and Wruh criteria, was excellent in 18 (62.06%), good in 6 (20.68%), fair in 3 (10.34%) and poor in 2 (6.89%) for SIGN nail whereas it was 16 (57.14%), 8 (28.57%), 3 (10.71%) and 1 (3.57%) respectively for hollow nail. There was 1 case of implant failure and 1 case of infection. Intraoperative blood loss (397 ± 94.47 ml versus 350 ± 75.43 ml, p = 0.037) and duration of surgery (94.8 ± 14.57 min versus 82.0 ± 12.36 min, p = 0.001) were significantly more in hollow nailing group. At final follow up, overall pain on weight bearing (VAS score) and radiological union (RUST score) were 2.1 and 11.7 for SIGN nailing while they were 2.7 and 11.3 respectively for hollow nailing.(p = 0.41 and 0.45 respectively) The malrotation (p = 1.000), shortening (p = 1.000), varus-valgus angulation (p = 0.511), AP angulation (p = 0.706), ROM ankle (p = 0.239) and ROM knee (p = 0.086) were similar.

Conclusion: Solid SIGN nailing gives comparable functional outcome as conventional hollow nailing for tibia shaft fracture. For developing world with limited resources, SIGN nail is useful which is supplied freely and is designed to be used without image intensifier and fracture table.