BACKGROUND:
The use of recombinant human bone morphogenetic protein-2 (rhBMP-2) to improve the healing of open tibial shaft fractures has been the focus of two prospective clinical studies. The objective of the current study was to perform a subgroup analysis of the combined data from these studies.

METHODS:
Two prospective, randomized clinical studies were conducted. A total of 510 patients with open tibial fractures were randomized to receive the control treatment (intramedullary nail fixation and routine soft-tissue management) or the control treatment and an absorbable collagen sponge impregnated with one of two concentrations of rhBMP-2. The rhBMP-2 implant was placed over the fracture at the time of definitive wound closure. For the purpose of this analysis, only the control treatment and the Food and Drug Administration-approved concentration of rhBMP-2 (1.50 mg/mL) were compared. Patients who anticipated receiving planned bone-grafting as part of a staged treatment were excluded from enrollment.

RESULTS:
Fifty-nine trauma centers in twelve countries participated, and patients were followed for twelve months postoperatively. Two subgroups were analyzed: (1) the 131 patients with a Gustilo-Anderson type-IIIA or IIIB open tibial fracture and (2) the 113 patients treated with reamed intramedullary nailing. The first subgroup demonstrated significant improvements in the rhBMP-2 group, with fewer bone-grafting procedures (p = 0.0005), fewer patients requiring invasive secondary interventions (p = 0.0065), and a lower rate of infection (p = 0.0234), compared with the control group. The second subgroup analysis of fractures treated with reamed intramedullary nailing demonstrated no significant difference between the control and the rhBMP-2 groups.

CONCLUSIONS:
The addition of rhBMP-2 to the treatment of type-III open tibial fractures can significantly reduce the frequency of bone-grafting procedures and other secondary interventions. This analysis establishes the clinical efficacy of rhBMP-2 combined with an absorbable collagen sponge implant for the treatment of these severe fractures.





Polls results
1

On a scale of 1 to 10, rate how much this article will change your clinical practice?

NO change
BIG change
100% Article relates to my practice (18/18)
0% Article does not relate to my practice (0/18)
0% Undecided (0/18)
2

Will this article lead to more cost-effective healthcare?

61% Yes (11/18)
22% No (4/18)
16% Undecided (3/18)
3

Was this article biased? (commercial or personal)

22% Yes (4/18)
66% No (12/18)
11% Undecided (2/18)
4

What level of evidence do you think this article is?

22% Level 1 (4/18)
22% Level 2 (4/18)
27% Level 3 (5/18)
27% Level 4 (5/18)
0% Level 5 (0/18)