BESTT rhBMP-2

Recombinant human bone morphogenetic protein-2 for treatment of open tibial fractures: a prospective, controlled, randomized study of four hundred and fifty patients

Govender S, Csimma C, Genant HK, et al. The Journal of bone and joint surgery. American volume 2002 · PMID 12473698 · doi:10.2106/00004623-200212000-00001

Question

Does rhBMP-2 on an absorbable collagen sponge improve healing of open tibial fractures treated with intramedullary nailing?

Design

International multicentre randomised controlled trial (BMP-2 Evaluation in Surgery for Tibial Trauma).

Patients

450 adults with open tibial shaft fractures treated with debridement and intramedullary nailing.

Intervention

rhBMP-2 on absorbable collagen sponge at 0.75 or 1.5 mg/mL at wound closure

Comparison

Standard care (nailing and soft-tissue management)

Primary outcome

Proportion requiring secondary intervention for delayed union or nonunion at 12 months

Key result

The higher dose of rhBMP-2 significantly reduced secondary interventions, accelerated healing and reduced infection rates, particularly in Gustilo type III injuries.

Limitations

Industry-funded, mostly unreamed nails, and the benefit was less evident in later reamed-nail studies; cost and safety concerns limit routine use.

Impact on practice

The pivotal trial leading to licensing of rhBMP-2 in open tibial fractures; in UK practice BMPs are reserved for selected high-risk or recalcitrant cases rather than routine use.