In this study, OsteoAMP® bone graft showed superior fusion rates as compared to rhBMP-2 at all timepoints (p<0.004). Additionally, OsteoAMP® bone graft had >80% few adverse events as compared to rhBMP-2. Adverse events and complications related to use of rhBMP-2 have raised many ethical, legal, and reimbursement concerns for surgeons. OsteoAMP® bone graft is an allograft derived growth factor, rich in osteoinductive, angiogenic, and mitogenic proteins. The following data displays a blinded, multi -center study evaluating and comparing fusion outcomes between rhBMP-2 and OsteoAMP® bone graft.Summary
Introduction
Finger arthroplasty lacks the success seen with hip and knee joint replacements. The Van Straten Leuwen Poeschmann Metal (LPM) prosthesis was intended for the proximal interphalangeal (PIP) joints. However revision rates of 30% after 19 months were reported alongside massive osteolysis. Three failed LPM titanium niobium (TiNb) coated cobalt chrome (CoCr) components were obtained- two distal and one proximal. All three components were analysed using an environmental scanning electron microscope (ESEM). This gave the chemical composition of the surface to determine if the TiNb surface coating was still intact. The distal components were analysed using a ZYGO non-contact profilometer (1nm resolution) with the proximal component unable to be analysed due to its shape. ZYGO analysis gave the roughness average (Ra) of the surface and determined the presence of scratches, pitting and other damage. Images obtained from both the ZYGO and the ESEM indicated that the surfaces of all components were heavily worn. On the articulating surfaces of both distal components unidirectional scratching was dominant, while the non-articulating surface showed multidirectional scratching. The presence of unidirectional scratching suggested two-body wear, whilst the multidirectional scratching on the non-articulating surface of the distal component suggested that trapped debris may have caused three-body wear. The ESEM chemical analysis showed that in some regions on the distal component the TiNb coating had been removed completely and in other areas it had been scratched or penetrated. On the proximal component the TiNb coating had been almost completely removed from the articulating surfaces and was only present in small amounts on the non-articulating surfaces. There was little evidence of bone attachment to the titanium coating which was intended to help provide fixation. ESEM images showed the coating had been removed in some sections where there was minimal scratching, suggesting this scratching did not impact significantly in the coating removal. Therefore here the main cause of coating removal may have been corrosion, although scratching may have also have played a part. The osteolysis reported clinically may have been linked to the wear debris from the failed coating.
