Table 3.

Summary of selected clinical trials of recombinant human bone morphogenetic protein-7 (OP-1) use in the treatment of acute fractures and nonunions

Investigator and study design	Study groups	Outcome measures and follow-up (F/U)	Results
Calori et al. [86] (2008) Prospective randomized study	One hundred twenty patients with long bone nonunion were randomly assigned to receive rhBMP-7 (n = 60) or platelet-rich plasma (n = 60).	Clinical and radiographic union at 9 months Minimum F/U: 9 months	Higher union rates (86.7%), shorter healing time, and decreased number of secondary interventions with rhBMP-7 treatment
Ekrol et al. [40] (2008) Prospective randomized study	Thirty patients with distal radius malunion undergoing corrective osteotomy (stabilized with external fixator or pi plate) were randomly assigned to receive rhBMP-7 (n = 14) or autologous ICBG (n = 16).	Clinical, radiographic, and functional outcome measures Minimal F/U: 1 year	Time to healing was faster in patients who received autologous ICBG when compared with rhBMP-7 (in conjunction with a pi plate).
Ristiniemi et al. [87] (2007) Prospective study with matched controls	Twenty distal tibia fractures treated with external fixator and rhBMP-7 were compared with 20 matched controls that were treated with external fixator alone.	Time to healing, rate of secondary interventions, duration of external fixator, and time away from work	Early radiographic healing, higher union rates, reduced time for which the external fixator was required, and significant reduction in the time away from work in the rhBMP-7 group
		F/U: 1 year
Bilic et al. [88] (2006) Prospective randomized study	Seventeen patients with proximal pole scaphoid fractures were randomly assigned to receive autologous ICBG (n = 6), autologous ICBG+rhBMP-7 (n = 6), or allograft+rhBMP-7 (n = 5).	Clinical and radiographic (x-rays, computed tomography scans, bone scan) outcomes measures F/U: 2 years	Enhanced bone healing and reduced healing time in the rhBMP-7 treatment groups compared with the autologous ICBG group
McKee et al. [89] (2002) Prospective randomized trial with preliminary results only	One hundred twenty-four open tibial shaft fractures treated with irrigation and debridement and intramedullary nailing were randomly assigned to receive OP-1 (n = 62) or no treatment (n = 62) at the time of final wound closure.	Radiographic and clinical Time to healing and rate of secondary interventions Minimum F/U: 6 months	Significant reduction in the number of secondary interventions with OP-1 treatment
Friedlaender et al. [39] (2001) Prospective, randomized, partially blinded multicenter trial	One hundred twenty-four tibial nonunions treated with intramedullary rod insertion were randomly assigned to receive either rhBMP-7 or autograft.	Clinical and radiographic measures F/U: 9 months	No significant differences in the clinical and radiographic results between the rhBMP-7 and the autologous bone graft groups
Geesink et al. [90] (1999) Prospective, randomized, and double-blinded trial	Twenty-four patients with fibular osteotomy were prospectively randomly assigned to receive rhBMP-7 + collagen matrix (n = 6), collagen carrier (n = 6), demineralized bone (n = 6), or no treatment (n = 6).	Clinical, radiographic, and dual-energy x-ray absorptiometry scan F/U: 1 year	Improved healing rates of fibular defects (5/6) with the rhBMP-7 treatment

ICBG, iliac crest bone graft; rhBMP-7, human recombinant bone morphogenetic protein-7.