Bone defect healing with an osteogenic protein‐1 device combined with carboxymethylcellulose

Abstract

One consideration for the practical use and application of osteogenic proteins is an effective method of delivery. This study evaluated a putty‐type collagen carrier with recombinant human osteogenic protein‐1 (rhOP‐1) ability to heal canine critical sized (2.5 cm) ulna segmental defects compared to rhOP‐1 with a particulate collagen carrier (OP device). The addition of carboxymethylcellulose (CMC) to the particulate collagen carrier (OPCMC device) to form the putty consistency was evaluated in two doses (3.5 and 1.75 mg rhOP‐1/g carrier). The CMC greatly improved the intraoperative handling and site containment of the device. For the one‐half dose and full‐dose sites there were no statistically significant differences in the radiographic grading of defect healing when treated with the particulate OP‐1 device and the device with CMC added. However, there was a dose effect with greater and earlier new bone formation observed with increased rhOP‐1. Mechanically, there were no differences between particulate and putty formulations, although again, a significant effect was observed for treatment dose with the full‐dose OPCMC device restoring 94% of the strength of the intact ulna compared to only 65% for the identical one‐half dose implant. Regardless of rhOP‐1 dose, the quality of union grading and total histologic score appearance were improved with the addition of CMC, although differences in histologic scoring were not statistically significant. Overall, the radiographic, mechanical, and histologic bone‐healing characteristics with the one‐half dose OPCMC device were similar to sites treated with the full‐dose OP device. The observed improvement in healing may allow for lesser amounts of the device or a device with less rhOP‐1 to be used. © 2005 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 2005