Title: Recombinant Human Bone Morphogenetic Protein-2 in Open Tibial Fractures: A Subgroup Analysis of Data Combined from Two Prospective Randomized Studies
Authors: Marc F. Swiontkowski, MD, Hannu T. Aro, MD, PhD, Simon Donell, MD, John L. Esterhai, MD, James Goulet, MD, Alan Jones, MD, Philip J. Kregor, MD, Lars Nordsletten, MD, PhD, Guy Paiement, MD and Amratlal Patel, MD
Source: The Journal of Bone and Joint Surgery (American). 2006; 88:1258-1265.
PODIATRIC RELEVANCE:
Among the advances in healing of fractures and osteotomies of the foot and leg the use of recombinant BMP products are becoming more used and useful for the podiatric surgeon. The use of a specific rhBMP-2 to improve healing in open tibial shaft fractures was the focus of the two studies assessed in this article. The objective of this study was to perform a subgroup analysis of the combined data from these studies.
METHODS:
In this article two prospective, randomized clinical studies were undertaken with a total of 510 patients. All of whom had open tibial fractures and 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. Only the control treatment and the Food and Drug Administration-approved concentration of rhBMP-2 (1.50 mg/mL) were compared for this analysis. The rhBMP-2 implant was placed over the fracture at the time of definitive wound closure and the patients who anticipated receiving planned bone-grafting as part of a staged treatment were excluded from enrollment.
RESULTS:
All of the 510 patients that were followed from fifty-nine trauma centers in twelve countries were followed up for twelve months postoperatively. There were two subgroups analyzed: (1) the 113 patients treated with reamed intramedullary nailing and (2) the 131 patients with a Gustilo-Anderson type-IIIA or IIIB open tibial fracture. The second 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 primary subgroup analysis of fractures treated with reamed intramedullary nailing demonstrated no significant difference between the control and the rhBMP-2 groups.
COMMENTS:
This double prospective analysis establishes the clinical efficacy of rhBMP-2 combined with an absorbable collagen sponge implant for the treatment of the above described severe fractures. The addition of rhBMP-2 to the treatment of type-III open tibial fractures significantly reduced the frequency of bone-grafting procedures and other secondary interventions during this study.
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Disclaimer:
Scientific Abstract Monthly postings are submitted by podiatric surgical residents. The ideas presented are not the opinions of the American College of Foot and Ankle Surgeons (ACFAS), nor are they presented as facts. ACFAS presents this information without any warranty of any kind, expressed or implied, and is not liable for its accuracy nor for any loss or damage caused by the user's reliance on information obtained in these areas.