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.