The effect of a biphasic injectable bone substitute on the interface strength in a rabbit knee prosthesis model

Abstract

BackgroundIn joint prosthetic surgery, various methods are used to provide implant stability. We used an injectable bone substitute, composed of calcium sulfate/hydroxyapatite, as bone defect filler to stabilize a tibia prosthesis in an experimental rabbit model. The aim of the study was to investigate and compare the stability of prosthetic fixation with and without the use of an injectable bone substitute.MethodsSixteen rabbits were used and the tibia prostheses were implanted bilaterally, one side with the prosthesis alone and the other side with the prosthesis and calcium sulfate/hydroxyapatite (Cerament™). The rabbits were randomly divided into two groups and euthanized after 6 and 12 weeks, respectively. The prosthesis was extracted measuring the pull-out force in an Instron tester, and the bone surrounding the former prosthesis site was analyzed by histology, histomorphometry, and micro-computed tomography.ResultsAt 6 weeks no difference in maximum pull-out force was found between the prostheses fixed with or without Cerament™. At 12 weeks the maximum pull-out force for the prostheses with Cerament™ was significantly higher than that for the prostheses without Cerament™ (p = 0.04). The maximum pull-out force at 12 weeks was significantly higher than that at 6 weeks for the prostheses fixed with Cerament™ (p = 0.03) but not for the prostheses without.ConclusionWe conclude that early prosthesis-bone interface strength is not influenced by a bone substitute. However, during remodeling, the bone substitute might provide improved mechanical support for the prosthesis. The results support further studies of the use of injectable calcium sulfate/hydroxyapatite in fixation of prosthetic joint implants.

Calcium-Based, Antibiotic-Loaded Bone Substitute as an Implant Coating: A Pilot Clinical Study

“…Cerament G and Cerament V incorporate gentamicin sulphate (175 mg/10 mL) and vancomycin (66 mg/mL), respectively, and preclinical studies have demonstrated their efficacy in treating infected bone defects 16 and no detrimental effects on osteointegration when used as a coating on implants 17.…”

Implantation of an Injectable Bone Substitute Material Enables Integration Following the Principles of Guided Bone Regeneration

“…Alloplastic bone substitutes, especially hydroxyapatite (HA), alpha-and beta-tricalcium phosphate (α-TCP and β-TCP) and biphasic calcium phosphate ceramics are viable alternatives to autogenous, allogeneic and xenogeneic bone grafts in surgical bone augmentation and replacement (1). Even though they lack some of the qualities of autografts, allografts and xenografts such as osteogenesis and osteoinduction, alloplastic bone substitutes are osteoconductive (2)(3)(4)(5)(6), readily available in different easy-to-use forms (7)(8)(9), and pose no risk of disease transmission or morbidities associated with bone graft harvesting (10)(11)(12). It has been shown that these biomaterials are mainly degraded by the process of phagocytosis, which is affected by the chemical composition and physical characteristics of a biomaterial.…”

“…For BBSMs, the tissue reaction is formed by the individual reactions towards each of the material compounds. Therefore, aspects such as biodegradation is based on the activity of phagocytes such as macrophages and BMGCs towards the individual compounds (10,12,17,(20)(21)(22)(23)(24)(25)(26). Hence, BBSMs initially induce an inflammatory tissue reaction similar to that of a pure β-TCP material, resulting in a high number of BMGCs and a high degradation rate, at later stages this is followed by a slower degradation rate correlated with lower BMGC numbers at a later, which can be compared to pure HA (17).…”

“…It has also been revealed that BBSMs induce tissue reactions that may support the bone regeneration process (17,20,32). Thus, BBSMs have been shown to be favorable materials for bone tissue regeneration in different preclinical and clinical studies (10,12,17,20,21,23,24,(32)(33)(34).…”

“…However, different clinical cases such as fracture cavities, interspaces around a screw or cysts, necessitate the application of an injectable bone substitute (IBS) (2,11,12,22,29,31,(35)(36)(37)(38). This material class provides different benefits such as a minimally-invasive application and an optimal filling capability of irregularly shaped defects up to the defect borders (2,31).…”