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Adding rhBMP-2 to open tibial fractures treated with intramedullary reamed nailing had no benefit
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NEW ORLEANS — Recombinant human bone morphogenetic protein-2 did not improve healing of open tibial fractures treated with intramedullary reamed nailing, according to the results of an international multicenter clinical trial.
Finnish investigator and lead author of the study, Hannu T. Aro, MD, presented the study at the 2010 Annual Meeting of the American Academy of Orthopaedic Surgeons, here.
“In our previous clinical trial … recombinant human BMP-2 improved fracture healing in patients treated with unreamed intramedullary nailing,” he stated. “However, the benefits of BMP-2 remain unclear in patients treated with reamed nailing. Therefore, we evaluated the efficacy and safety of BMP-2 in the treatment of open tibia fractures fixed with reamed intramedullary nails.”
Single-blind study
The study included 277 patients with open tibia fractures, randomly assigned in a single-blind fashion to undergo reamed intramedullary nailing either with or without the implantation of a collagen sponge containing recombinant human bone morphogenetic protein-2 (rhBMP-2; Infuse, Medtronic). Patients were clinically and radiographically observed for 1 year postoperatively; 80% of the patients completed the 1-year follow-up, Aro said.
The BMP-2 group included 139 patients, and the control group included 138 patients: 30% of the fractures in both groups were classified as Gustilo-Anderson type IIIB.
Primary efficacy endpoint
“The primary efficacy endpoint was the proportion of subjects with healed fractures at either 13 or 20 weeks,” Aro said. “The criteria of healed fracture required the absence of local tenderness and/or pain during weight-bearing, radiographic union, no hardware failure resulting in dynamization, and no secondary procedure to promote healing recommended or performed.”
He noted a fracture healing rate of 60% in the BMP-2 group and 48% in the control group at 13-week follow-up. This was not statistically significant, and at 20-week follow-up, “this trend had disappeared.”
Local infections
Although the incidence of adverse events was also comparable between the two groups, more delayed unions and nonunions occurred in the control group.
However, a high incidence of local infections occurred in the BMP-2 group, which led the investigators to discontinue the study before reaching the planned total of 300 patients. Aro said, “Most infections occurred within 3 months after treatment. Careful review did not reveal confounding factors that could explain the appearance of these infections.”
He concluded, “Unlike with unreamed nails, the healing of open tibial fractures treated with reamed nailing was not significantly accelerated by the local addition of BMP-2, and there was a trend for a higher incidence of infections. The reason for this numerical increase in infections remains unclear and contradicts the results of previous studies. For simple Gustilo I wounds, we speculate that the sponge may have been contaminated by contact of the sponge with the wound margins.” – by Thomas M. Springer
Reference:
- Aro HT, Govender S, Patel AD, et al. Recombinant human bone morphogenetic protein-2 and reamed intramedullary nailing of tibia fracture. Paper# 380. Presented at the 2010 Annual Meeting of the American Academy of Orthopaedic Surgeons. March 9-13. New Orleans.
- Hannu T. Aro, MD, can be reached at the University of Turku, Department of Surgery, Turku, FI-20520 Finland; +358-2-313-0000; e-mail: hannu.aro@utu.fi. He is on the speaker’s bureau for Merck and Novartis; he is an unpaid consultant for Bioretec Ltd and Vivoxid Ltd; and he has received research or institutional support from Novartis and Stryker (page 19).
