Long-term evaluation of a calcium phosphate bone cement with carboxymethyl cellulose in a vertebral defect model

We investigated histological and compressive properties of a calcium phosphate bone cement (Bone-Source (R) (CPC); Stryker Orthopaedics, Mahwah, New Jersey) plus carboxymethyl cellulose (CMC) using a sheep vertebral bone void model. Bone voids were surgically created in L3 and L5 in each of 40 sheep, and the voids were filled with the cement. Histological and radiographic evaluations were performed on one vertebral body from each animal at either: 0, 3, 6, 12, 24, or 36 months after surgery; mechanical testing was performed on operated and non-operated vertebral bodies from 35 sheep. Undecalcified sections were digitized, and the area of the original defect, new bone formation, empty space, fibrous tissue, and residual cement were quantified with histomorphometry. Decalcified sections were evaluated qualitatively. The cement was biocompatible, extremely osteoconductive and underwent steady resorption and replacement by bone and bone marrow. Histomorphometry showed variations in the rate of cement remodeling among animals in each time group, but on average, at 36 months the original defect area was occupied by similar to 14% bone, 82% cement, and 4% bone marrow. Even in animals that had greater resorption of cement, there was good bone ingrowth with no fibrous tissue. Compressive testing did not reveal a significant difference in the mechanical properties between vertebral bodies augmented with cement and non-augmented controls, irrespective of the postoperative time. BoneSource mixed with CMC had adequate osteoconductivity, biocompatibility, and adequate compressive strength. There was variability among animals but histology suggests that considerable cement was still present in most samples after 36 months. (c) 2008 Wiley Periodicals, Inc. J Biomed Mater Res 88A: 880-888, 2009