Application of BMP-7 to tibial non-unions: a 3-year multicenter experience.

SUMMARY: The effective treatment of the often debilitating, longlasting and large-asset-consuming complication of fracture non-unions has been in the centre of scientific interest the last decades. The use of alternative bone substitutes to the gold standard of autologous graft includes the osteoinductive molecules named bone morphogenetic proteins (BMPs). A multicenter registry and database (bmpusergroup.co.uk) focused on the application of BMP-7/OP-1 was created in December 2005. We present the preliminary results, using the prospective case-series of aseptic tibial non-unions as an example. Sixty-eight patients fulfilled the inclusion criteria for this observational study, with a minimum follow-up of 12 months. The median duration of tibial non-union prior to BMP-7 application was 23 months (range 9-317 mo). Patients had undergone a median of 2 (range 0-11) revision procedures prior to the administration of BMP-7. In 41% the application of BMP-7 was combined with revision of the fixation at the non-union site. Non-union healing was verified in 61 (89.7%) in a median period of 6.5 months (range 3-15 mo). No adverse events or complications were associated with BMP-7 application. The safety and efficacy of BMP-7 was verified in our case series, and was comparable to the existing evidence. The establishment of multicenter networks and the systematic and long-term follow- up of these patients are expected to provide further information and significantly improve our understanding of this promising osteoinductive bone substitute.

Recombinant human bone morphogenetic protein-7 for treatment of long bone non-union: an observational, retrospective, non-randomized study of 105 patients.

Autogenous bone-grafting is frequently used in the treatment of fracture non-union. The donor-site morbidity and potentially limited supply of suitable autogenous bone are commonly recognized drawbacks. Recent studies advocated the benefit and safety of recombinant human bone morphogenetic protein-7 (rhBMP-7) in several anatomical sites. An observational, retrospective, non-randomized study on the use of BMP-7 in treating non-union in various sites has been carried out by the BMP-7 Italian Observational Study (BIOS) Group. The clinical series included 105 patients. Additional grafts were used based on the surgeon's decision. Radiographic and clinical assessments were carried out at progressive time intervals on two groups: BMP-7+autograft (A) or BMP-7 (B). The mean follow-up was 29.2 months. The last assessment showed an 88.8% success rate with an average healing time of 7.9 months. At >/=9 months there was overlapping between the unions recorded in the two groups (PA-PB=1.5%; CI 95%: -0.149; 0.119). This is an observational study that illustrates the efficacy of BMP-7 with and without bone grafting for the treatment of long bone non-unions.