This involves a retrograde intramedullary nail with a unique “cruciate” configuration of distal locking bolts which stabilise the fractured condyles in relation to the shaft. The optimal geometrical configuration of the distal locking bolts has been developed using cadaver studies. Following finalisation of the design, mechanical bench testing of the implant and clinical trials have been completed according to a protocol agreed with the UK Medical Devices Agency. So far 36 patients have been treated using the implant which has proved to be effective and easy to use. Much less soft tissue dissection is required than when using conventional blade plates or DHS, or even newer “percutaneous” plating methods.
Following completion of clinical trials, the Medical Devices Agency has granted approval for general use of the implant. It is anticipated that this will greatly facilitate the management of distal femoral fractures particularly those involving intercondylar fracture patterns.