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Study finds rhBMP-2 significantly improves open tibial fracture healing

Patients treated with Infuse bone graft substitute required fewer secondary interventions and a lower infection rate.

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Adjunct use of the Infuse Bone Graft substitute can help accelerate the healing of severe tibial trauma, according to a study. It can also reduce the risk of nonunion or delayed union requiring secondary bone grafting, the authors noted.

The Infuse Bone Graft (Metronic Inc.) substitute contains recombinant human bone morphogenetic protein-2 (rhBMP-2). Marc F. Swiontkowski, MD, and colleagues at several centers in the United States and Europe, conducted two prospective clinical studies evaluating the product in patients with open tibial fractures. They published their findings in the American edition of The Journal of Bone and Joint Surgery.

The researchers randomly assigned 510 patients to either a control treatment (intramedullary nail fixation) or to control treatment plus one of two rhBMP-2 concentrations. Surgeons at 59 trauma centers participated in the study. In all cases, rhBMP-2 was applied using an absorbable collagen sponge placed over the fracture.

For the data analysis, the researchers compared only the control treatment against the FDA-approved 1.5 mg/ml rhBMP-2 concentration, however. Additionally, researchers analyzed two patient subgroups: 131 patients with Gustilo-Anderson type 3A or 3B open tibial fractures, and 113 patients whom surgeons treated with reamed intramedullary (IM) nailing, according to the study.

At 12 months' follow-up, patients with Gustilo-Anderson type 3A or 3B fractures who received treatment with rhBMP-2 had significantly better results, including the following:

• significantly fewer bone-grafting procedures (P=.0005);
• significantly fewer invasive secondary interventions (P=.0065); and
• a significantly lower infection rate (P=.0234).

However, the second subgroup analysis found no significant differences between patients treated with IM nailing alone and those treated with IM nailing plus rhBMP-2, according to the study.

Infuse Bone Graft was originally approved by the FDA in 2002 for anterior lumbar interbody spine fusion using specific spinal implants. In 2004, the FDA approved the bone graft substitute for use in open tibial fractures treated with IM nailing within 14 days of the initial fracture, according to a Medtronic press release.

For more information:

• Swiontkowski MF, Aro HT, Donell S, et al. Recombinant human bone morphogenetic protein-2 in open tibial fractures. J Bone Joint Surg. 2006;88-A:1258-1265.