Evaluation of the SMALL nail: Drive technology and behavior in situ

Although clear advances have been made during the last 5 years, practical difficulties persist for patients and surgeons in procedures for intramedullary lengthening of long bones. In particular, precise adjustment of the desired amount of lengthening and technically reliable checking of the length actually achieved are problematic. An intramedullary nail with a new type of drive that exploits the shape memory effect has been constructed. The drive technology and the behavior of the intramedullary nail in situ were evaluated in a cadaver experiment. Three shape memory alloy limb lengthening (SMALL) nails were implanted in a body donor. The SMALL nail contains a spring coupled to a shape memory element consisting of a nickel-titanium alloy. This shape memory element "remembers" its initial state before the lengthening through the spring and can return to it when it is warmed. A cartridge heater inside the lengthening nail is warmed using transcutaneous induction with high-frequency energy via a subcutaneously implanted coil. For evaluation, two SMALL nails were implanted into the femora (antegrade on the left and retrograde on the right) and one SMALL nail was implanted into the left tibia. Lengthening by 50mm was attempted using repeated activation of the drive mechanism. At the same time, test parameters for temperature increases and cooling periods were continually monitored and the data were subsequently analyzed. The nail's mechanism worked in principle, but was inadequate in view of success rates (number of lengthening steps attempted versus number of lengthening steps achieved) of 21% for the SMALL nail in the tibia and left femur and 14% for the nail in the right femur. The temperature values measured during the distraction experiments show that high-frequency energy induction in the SMALL nail gives no cause for concern for patients.