Fracture treatment using TiNi shape memory alloy bone fixater (BRM-SH system)

Titanium-Nickel shape memory alloy (TiNi SMA) has great potential as a biomaterial in orthopaedic applications due to its unique thermal shape memory effects, superelasticity and high damping properties. We designed and manufactured bone fixaters using newly developed TiNi SMA wire (Af, 35 ± 2°C). Two bone fixater designs (single and double ring) were prepared for the treatment of bone fracture in twenty patients (6 distal femur, 5 distal fibular, 4 distal tibia, 2 metacarpal bone, 2 periprosthetic fracture and 1 subtrochanter of femur). Serial radiographs, complete blood count (CBC) and urine analysis were performed postoperatively. Radiological union was achieved without complications in approximate eight weeks after operation. There were no abnormal findings on follow-up CBC or urine analysis. On a subjective level, use and application of the TiNi SMA fixater was not as demanding as conventional fixation methods, such as cerclage or the Dali-Miles technique. The efficacy of SMA bone fixater in this study is very excellent as demonstrated in this clinical study. It gives the new armament to orthopedic surgeon.