Table 2 Summary of selected clinical trials of recombinant human bone morphogenetic protein-2 use in the treatment of acute fractures and nonunions

Aro et al. [38] (2011)

Randomized, prospective, blinded study

Two hundred seventy-seven patients with open tibia fractures were randomly assigned to receive standard of care (SOC) (intramedullary nail and soft tissue management; n = 138) or SOC + rhBMP-2(1.5 mg/mL; n = 139).

Clinical and radiographic assessment of fracture healing, rates of secondary intervention

F/U: 1 year

rhBMP-2 did not significantly accelerate fracture healing in open tibia fractures compared with the controls. The study was halted prior to completion because of a trend toward increasing infection in the rhBMP-2 group.

Jones et al. [37] (2006)

Prospective, randomized, multicenter, controlled, and blinded study

Thirty diaphyseal tibia fractures with cortical defects were randomly assigned to two treatment groups: rhBMP-2 + allograft (n = 15) or autogenous ICBG (n = 15).

Clinical and radiographic assessment of fracture healing, functional outcome measure (SMFA)

No significant differences in the healing rates, number of secondary interventions, and functional outcome scores between the two groups

F/U: 1 year

Swiontkowski et al. [85] (2006)

Open tibia fractures were randomly assigned to receive intramedullary nail and routine soft tissue management alone (n = 169) or in combination with rhBMP-2 (n = 169).

Clinical and radiographic assessment of fracture healing, number of secondary interventions and infection rates

rhBMP-2 decreased the frequency and invasiveness of secondary interventions and reduced the infection rates in grade III open tibia fractures.

Subgroup analysis of two prospective randomized studies

Two subgroups: open fracture (grade IIIA and IIIB; n = 131) and the reamed nailing group (n = 113)

F/U: 1 year

Govender et al. [36] (2002) Prospective, randomized, multicenter, controlled, single-blind study

Four hundred fifty patients with open tibia fractures were randomly assigned to receive SOC (intramedullary nail and soft tissue management) or SOC + rhBMP-2 (0.75 mg/mL) or SOC + rhBMP-2 (1.5 mg/mL).

Clinical and radiographic assessment of fracture healing, rates of secondary intervention

F/U: 1 year

rhBMP-2 (1.5 mg/mL) use reduced the frequency and invasiveness of secondary interventions, reduced infection rate (grades IIIA and IIIB), and accelerated fracture and wound healing.