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.

Virk and Lieberman Arthritis Research & Therapy 2012 14:225   doi:10.1186/ar4053