Evaluation of New Biphasic Calcium Phosphate Bone Substitute: Rabbit Femur Defect Model and Preliminary Clinical Results

Abstract

Autogenous bone grafting, used to repair bone defects, is limited and the donor site can experience complications. Compared to autogenous bone graft, artificial bones have different porosity, which might make them suitable alternatives to bone grafts. Here, two porous biphasic calcium phosphate bone substitutes, namely Bicera™ and Triosite™, are used in an animal study and clinical practice to find a suitable porosity for implantation. Bicera™ and Triosite™ consist of 60 wt% hydroxyapatite and 40 wt% β-tricalcium phosphate, with the porosity of Bicera™ (82%) being higher than that of Triosite™ (70%). In the animal study, the implantation procedure was carried out on twenty-four female New Zealand rabbits. 12 weeks after implantation, the new bones were well infiltrated into the Bicera™ and Triosite™ bone grafts. In the clinical study, patients with comminuted fracture, fracture nonunion, or arthrodesis were included in the study of bone substitution with Bicera™. 27 patients underwent fracture fixation treatment. Bone healing of 22.22% (6/27) of patients happened within 3 months after the surgery, and that of 66.67% (18/27) of patients happened within 6 months. These results reveal that Bicera™ has good incorporation with host bone, and that new bone is able to grow within the porous structure, giving it high potential in the treatment of bone defects.

Bone formation following sinus grafting with an alloplastic biphasic calcium phosphate in Lanyu Taiwanese mini‐pigs

“…[57][58][59] For instance, the bone remodeling rates were quantitatively measured and the rates of 1.0 to 1.5 mm/day, 1.2 to 1.5 mm/day, and 1.5 to 2.0 mm/day reported for in humans, mini-pigs, and dogs, respectively. 47 Our results further showed that the bone mineralization surfaces (sLS/BS) at weeks 4 or 8 were different for the two grafted materials. 61 Similar to our results, the osteoinductive potential of a synthetic biphasic calcium phosphate bone graft has recently been suggested to be based on the findings of new bone formation noted in vitro and sub-cutaneous implantation.…”

“…43 Although the ideal ratio of HA to -TCP is still under investigation, [44][45][46] variant ratios of BCPs have been widely used for bone graft substitutes, with favorable results A review of the commercially available BCP indicated that the most common ratio is 60% HA and 40% -TCP. 47 One of the most used DBBMs for various augmentation procedures 15 was also selected in this study. 47 One of the most used DBBMs for various augmentation procedures 15 was also selected in this study.…”

“…60 A study on the effects of fluoride on cortical bone remodeling also showed that the mineralization rate is similar between growing domestic pigs and humans. The osteoconductivie and osteoinductive potentials, 47,62 as well as the early resorption of -TCP in substitutes, 19,20 might result in early bone formation for HA/TCP compared with DBBM. 62 In the present study, the techniques of µ-CT and histology were selected for qualitatively or quantitatively evaluating the augmented calcified tissue and their mineralization characteristics in sinuses after grafted with HA/TCP and DBBM particles.…”

Synergistic effect of strontium, bioactive glass and nano‐hydroxyapatite promotes bone regeneration of critical‐sized radial bone defects

“…Likewise, chitosan/β‐tricalcium phosphate (Chi/TCP) scaffold promoted bone regeneration of tibial defects in rabbit . Other composites such as alginate/hydroxyapatite, hydroxyapatite/gelatin nanocomposite, and biphasic calcium phosphate scaffolds have been used to enhance new bone formation. However, the majority of these materials and composites are osteoconductive and exhibit inadequate osteoinductivity for clinical applications.…”

Repair of a critical‐size segmental rabbit femur defect using bioglass‐β‐TCP monoblock, a vascularized periosteal flap and BMP‐2

“…Thus, optimal methods for the treatment of segmental bone defects, particularly weight‐bearing bone defects, are still sought. β‐TCP has been widely used as a scaffold for small bone defects due to its good osteoconductivity, but its clinical use is limited due to its rapid degradation rate and poor mechanical strength . Recently, bioglass has received growing attention because of its superior mechanical properties .…”