In this study BMPs/AGFs were used in posttraumatic long bone non-union and osseous defects to test their clinical and radiological effectiveness in order to find a valid alternative to autologous bone grafting.
Moreover, the overall recruitment period is 3 years during which 40 patients/year will be enrolled up to a total of 120 cases; half of these will be treated with rhBMP-7 and the other half with PRP.
Thanks to recombinant DNA technique it is now possible to synthesise recombinant human osteogenic protein 1 (rh OP1), one of the best documented osteogenic proteins. This protein, linked to type 1 collagen as carrier, is the first drug with proven osteoinductive and osteoconductive properties approved for clinical use. Osigraft (the commercial name of OP-1 and collagen) is also biocompatible, bioresorbable and lacks the risk of disease transmission. In the most challenging non-union, tibial non-union, the drug showed 80% efficacy as autograft with a better tolerability (i.e. lack of donor site complications) also in patients with previously failed autograft. Higher rates of success were also reported in recalcitrant long bone non-unions, i.e. a mean of 5 years of length of disease, incresaed number of previous surgeries. Osigraft, also considering its physical characteristics, has to be implanted during the surgical procedure, with direct positioning at the non-union site; furthermore, its use is contraindicated in cases of infection of bone and infection/poor condition of surrounding soft tissues. In our department we have treated up to now five patients with complex non-union of femoral neck and tibia; in three cases serious soft tissue conditions were present (crushing, infected necrosis) and one patient required plastic surgery. In all case we registered complete clinical and radiological healing after 3.5–7 months. We also describe two cases of closed application of Osigraft, pushing the drug into the non-union site via a holed cannulated nail with the help of a probe under radioscopic control.