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Treatment of Nonunions with Nonglycosylated Recombinant Human Bone Morphogenetic Protein-2 Delivered from aFibrinMatrix

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Abstract:

Objective

To report the results of the treatment of nonunions with nonglycosylated recombinant human bone morphogenetic protein-2 (nglBMP-2) delivered from a designed fibrin matrix. Study Design

Experimental trial in rodents and prospective clinical study in dogs and cats with nonunion fractures. Animals

Twenty adult female, albino, Sprague–Dawley rats; 8 client-owned cats and dogs. Methods

After development of a fibrin matrix and evaluation of nglBMP-2 in a rodent femoral defect model, 8 consecutive long bone nonunion fractures (no progression in healing in ≥3 months), were treated using 300 g nglBMP-2 in a liquid fibrin precursor, injected into the defect gap after fracture revision and stabilization, or through a stab incision into the fracture site. The fibrin matrix was designed to clot in the wound after 60 seconds and to release the nglBMP-2 continuously over several days. Results

Using only fibrin gel, 7% of the rat femoral defect was filled with new formed bone compared with 79% defect filling using 2g nglBMP-2 (P=.006). Five and 10 g nglBMP in fibrin resulted in union of all femoral defects with complete filling of the gap with new bone. Bony bridging and clinical healing was achieved in 7 patients within 24 weeks of administration of nglBMP-2. Conclusions

Application of nglBMP-2 in a functional matrix can induce bone healing. Controlled release of nglBMP-2 from a fibrin matrix mimics the natural fracture hematoma. Clinical Relevance

nglBMP-2/fibrin can successfully replace a cancellous bone autograft in fracture treatment with an associated reduction in graft donor site morbidity and surgical time.

Document Type: Research Article

DOI: http://dx.doi.org/10.1111/j.1532-950x.2004.04018.x

Affiliations: From the Department of Clinical Veterinary Medicine, University of Berne, Berne; the Clinic for Maxillofacial Surgery, University Hospital, Zurich; the Institute for Biomedical Engineering ETH, Zurich; the Department of Veterinary Surgery, Musculoskeletal Research Unit, University of Zurich; and Kuros Biosurgery, Zurich, Switzerland.

Publication date: March 1, 2004

bsc/vsu/2004/00000033/00000002/art00004
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