Efficacy of Bone Source™and Cementek™in Comparison with Endobon™in Critical Size Metaphyseal Defects, Using a Minipig Model

Abstract

To examine and compare biocompatibility, osteocompatibility, rate of resorption, and remodelling dynamics of 2 calcium phosphate cements in comparison with a well-established hydroxyapatite ceramic. In a randomised fashion, Bone Source™, Cementek™, and Endobon™ were implanted bilaterally into the proximal metaphyseal tibiae of 35 Göttinger minipigs in a direct right vs. left intra-individual comparison. Fluorescent labelling was used. Histological and morphometric evaluations were carried out at 6, 12, and 52 weeks. All bone substitutes showed good biocompatibility, bioactivity, and osteoconductivity. Endobon™ was not degraded over the follow-up period. Cementek™ was degraded constantly and significantly over the time intervals, whereas Bone Source™ was degraded mainly from the 6 week to 12 week interval. After 52 weeks, a significant difference of residual material within the defect zone was detected between all substitutes, with the highest resorption rate for Cementek™. Bone Source™ was least degraded. Defects filled with Endobon™ were characterised by a significantly continuous bony ingrowth over the time intervals. Bone formation within the defects filled with Cementek™ and Bone Source™ showed significant peaks 12 weeks after implantation. After 52 weeks, a significant difference in the amount of new bone within the defect area was detected, with the highest levels for Endobon™, followed by Cementek™. After 1 year a restitution ad integrum could not be observed in any treatment group. The ceramic Endobon™ showed the expected response histologically. Based on its porosity it excelled in osteoconductivity. Concerning the calcium phosphate cements, a thorough osseous incorporation seemed to inhibit further degradation of both bone substitute materials.