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Safety and efficacy of recombinant human bone morphogenetic protein 2 on cranial defect closure in the pediatric
Omar E Beidas1, Jordan C Deschamps-Braly, Aaron M Morgan
1Division of Plastic Surgery, Department of Surgery, College of Medicine, The University of Oklahoma, Oklahoma City, Oklahoma 73104, USA.
Insights
Recombinant human bone morphogenetic protein 2 (rhBMP-2) enhanced cranial bone graft closure for defects up to 16 cm. While effective, potential adverse effects like suture fusion were noted in a small number of patients.
Area of Science:
- Craniofacial surgery
- Regenerative medicine
- Biomaterials
Background:
- Autogenous bone grafts are standard for cranial defects but challenging in pediatric patients due to limited donor sites.
- Synthetic materials pose risks including infection and unknown long-term effects on skull growth.
- Bone morphogenetic protein 2 (BMP-2) shows promise in animal models for cranial defect repair.
Purpose of the Study:
- To compare the efficacy and safety of cranial defect closure using bone graft augmented with recombinant human BMP-2 (rhBMP-2) versus bone graft alone.
Main Methods:
- Retrospective multicenter study of 36 patients over 5 years.
- Compared 21 patients receiving rhBMP-2 augmented grafts with 15 patients receiving grafts alone.
- Volumetric CT scans measured preoperative and postoperative defect sizes.
Main Results:
- The rhBMP-2 group showed improved proportional closure (86%) compared to the control group (76%).
- No adverse effects directly linked to rhBMP-2 were observed, such as brain edema or airway compromise.
- Two patients in the rhBMP-2 group experienced postoperative fusion of previously patent sutures.
Conclusions:
- rhBMP-2 may enhance cranial bone graft integration for defect closure.
- Defects up to 16 cm can be reliably treated with rhBMP-2 augmented grafts.
- Potential for unreported adverse effects, like suture fusion, must be considered alongside the benefits of improved defect closure.
Background:
Traditional reconstructive options for cranial defects include autogenous bone graft, bone substitutes, and synthetic materials. The established standard for repairing cranial defects is autogenous bone. However, young children do not have abundant donor sites for bone harvest, which leads to challenges in closing calvarial defects. Synthetic materials are not ideal alternatives because they require subsequent retrieval and are prone to infection. Their long-term effects on growth of the skull are also not well studied. Bone morphogenetic protein 2 (BMP-2), are shown to positively affect closure of cranial defects in animal models. We present a study comparing the efficacy and safety of closure of cranial defect with bone graft augmented with recombinant human BMP-2 (rhBMP-2) and compared with a series of patients treated with bone graft alone.
Methods:
This study is a retrospective multicenter evaluation of 36 patients spanning 5 years. Twenty-one patients undergoing cranial defect closure augmented with rhBMP-2 were compared with 15 patients who underwent cranial defect closure using cranial bone shavings alone. We measured preoperative and postoperative defect size on volumetric computed tomographic scan reconstructions to compare defect sizes.
Results:
The rhBMP-2 group had slightly increased proportional closure compared with the control group, 86% versus 76% (P < 0.018), respectively. Two patients in the rhBMP-2 group had postoperative fusion of a suture that was known to be patent at the time of cranial defect closure. No instances of brain edema, herniation, airway compromise, or other adverse effects directly attributable to rhBMP-2 were observed.
Conclusions:
Bone morphogenetic protein 2 may increase the amplitude and uptake of cranial bone grafts in cranial defect closure. This study shows that defect sizes of up to 16 cm can be reliably closed using this technique. Postoperative fusion of uninvolved sutures in 2 patients indicates that rhBMP-2 may have unreported adverse effects; consideration of this finding should be weighed against the benefit of improved closure of calvarial defects.
