Abstract
Osteogenic protein 1 (OP-1) is involved in physiologic bone formation during development and promotes normal healing process after fractures. The protein has been produced in cells with genetic engineering techniques: recombinant human OP-1 (rhOP-1). The safety and effectiveness of rhOP-1 in healing tibial non-unions has been demonstrated in a clinical study: OP-1 provided clinical and radiographic results comparable with those achieved with iliac crest autograft, the gold standard in the treatment of non-unions. Furthermore, several publications have shown its efficacy in resistant long bone non-unions, too.
OP-1 was introduced into clinical routine in Italy in August 2002. In the Ospedale Marino of Alghero the authors have utilised OP-1 since October 2002 and present the first eight patients treated up to October 2003. The eight patients had a diagnosis of non-union dated from 4 to 20 months. Three patients had diaphyseal humeral non-union, three diaphyseal radial non-union, one meta-epiphyseal tibial non-union and one femoral non-union at 1/3 distal segment. Non-unions were exactly divided into atrophic and hypertrophic. In all patients synthesis was suitable (IM nail, n=5; plates, n=2; and staple, n=1). In six out of eight cases the synthesis was substituted for a non-suitable one. All but one patient (not previously treated fracture) had undergone one or two previous operations. In four cases OP-1 was mixed with fibrin glue (Tissucol) to help the placing. In all patients union was achieved after a mean of 5.5 months. No adverse event has been recorded.
