Aims

Therapeutic agents that prevent chondrocyte loss, extracellular matrix (ECM) degradation, and osteoarthritis (OA) progression are required. The expression level of epidermal growth factor (EGF)-like repeats and discoidin I-like domains-containing protein 3 (EDIL3) in damaged human cartilage is significantly higher than in undamaged cartilage. However, the effect of EDIL3 on cartilage is still unknown.

The treatment of acute full thickness chondral damage within the knee is a surgical challenge. Frequently used surgical techniques include chondroplasty, micro-fracture and chondrocyte implantation. These procedures give unpredictable functional outcomes and if the formation of neocartilage is achieved it is predominantly composed of type 1 collagen.

The TruFit osteochondral plug was designed to provide a scaffold for cell proliferation into full thickness chondral defects. It is a composite polymer composed of polylactide co-glycolide, calcium sulphate and poly-glycolide fibres. It is composed of 2 layers, one with a similar trabecular network to cancellous bone and a superficial layer designed to simulate articular lining.

The TruFit bone plug was analysed using micro-computed tomography. Its morphology characteristics, granulometry, mechanical performance and image guided failure were tested as well as numerical modelling to assess the permeability of TruFit.

Morphological parameters of the TruFit bone plug compared favourably with those of human tissue. Under load the scaffold exhibited shear bands throughout the composite leading to a failure mechanism similar to cancellous bone. Stress relaxation rates of the scaffolds were greatly decreased under wet conditions, likely due to plasticisation of the scaffold by water.

The biomechanical properties of the TruFit bone plugs are a cause for concern. The Scaffolds mechanical performance under load rapidly deteriorates in wet conditions at body temperature (the natural knee environment). This early failure will lead to defects in the articular surface where the plug has been inserted. Clinical data is sparse. This study correlates with work performed by Dockery et al & Spalding et al. These clinical studies have shown that the TruFit implant shows no evidence of bone ingrowth or osteoconductivity. It provides no subchondral support to neocartilage or tissue that was stimulated to form around the defects and surgical sites.

Introduction

Novel hydrogel implants, TRUFIT® bone plugs, have been developed by Smith & Nephew to replace worn-out cartilage surfaces, restoring mobility and relieving joint pain. There is limited information, however, on the biomechanical properties of the implants. Therefore, appropriate mechanical testing and modelling must be carried out to assess their mechanical properties for load bearing applications.

In this study, compressive properties of TRUFIT® bone and dual layer implants were examined under selected physiological loading conditions. The bone layer of the implant was also modelled using a biphasic poroviscoelastic (BPVE) material constitutive law and the results from the model are compared with those from the experiments.

Introduction: Calcium phosphate based ceramics with a porous configuration are attraction for use as synthetic bone grafts as the porous network allows tissue ingrowth, which further enhances the implant-tissue attachment. The degree of interconnectivity and the nominal pore size are the critical factors that determine the success of the implants. It is generally accepted that a minimum pore size of 100 μm is necessary for the porous implant materials to function well and a pore size greater than 200 μm is an essential requirement for osteo-conduction. However, research has suggested that the degree of interconnectivity is more critical than the pore size. In this study, porous Hydroxyapatite/Tricalcium phosphate (HA/TCP) bioceramics with interconnected porosity and controlled pore sizes were fabricated by a novel technique involving vacuum impregnation of reticulated polymeric foams with ceramic slip. HA/TCP samples with a range of pore sizes and functionally gradient materials (FGM) with porosity gradients were made.

Materials and Methods: Two grades of calcium phosphate powder, TCP 118 and TCP 130, were used. Varying the blend ratios could change the ratios of HA and TCP in the sintered samples. The foams used comprised polyurethane (PU) which had one of three different porosities 20, 30 and 45 pores per inch (ppi). In order to make a FGM with porosity gradients mimicking the bimodal structure of cortical and cancellous bone, two different foams were either joined together by sewing or pressfitting together. The foams were substantially impregnated with slip by vacuum impregnation. The impregnated foams were removed from the vacuum chamber and dried on tissue for at least 24 hours then sintered at temperatures of up to 1280°C.

Results and Discussion: Using a slip with the appropriate viscosity, porous HA/TCP bioceramics having interconnecting pores and a range of pore sizes can be produced successfully. By joining different ppi foams together, it is possible to develop functional gradient materials in which the porosity varies through the thickness of the samples. No weakness could be seen at the interface between the two different structures. This demonstrated that porous HA/TCP with two or more different levels of porosity could be produced in a single block. Image analysis shows the porosity measured for the three different foams was similar. The area equivalent diameters of the pore structure are 197–254 μm with 20ppi foam, 143–183 μm with 30ppi foam and 105–127 μm with 45ppi foam. The compressive strengths of the HA/TCP samples are in the range of 30–170 MPa and the apparent densities were 2.34–2.76 g/cm3. The technique developed for fabricating porous bioceramics can be extended to produce a range of bone substitute materials with properties tailored to specific clinical applications.