Bone graft substitutes in orthopedic applications have to fulfill various demanding requirements. Most calcium phosphate (CaP) bone graft substitutes are highly porous to achieve bone regeneration, but typically lack mechanical stability. This study presents a novel approach, in which a scaffold structure with appropriate properties for bone regeneration emerges from the space between specifically shaped granules. The granule types were tetrapods (TEPO) and pyramids (PYRA), which were compared to porous CaP granules (CALC) and morselized bone chips (BC). Bulk materials of the granules were mechanically loaded with a peak pressure of 4 MP; i.e., comparable to the load occurring behind an acetabular cup. Mechanical loading reduced the volume of CALC and BC considerably (89% and 85%, respectively), indicating a collapse of the macroporous structure. Volumes of TEPO and PYRA remained almost constant (94% and 98%, respectively). After loading, the porosity was highest for BC (46%), lowest for CALC (25%) and comparable for TEPO and PYRA (37%). The pore spaces of TEPO and PYRA were highly interconnected in a way that a virtual object with a diameter of 150 µm could access 34% of the TEPO volume and 36% of the PYRA volume. This study shows that a bulk of dense CaP granules in form of tetrapods and pyramids can create a scaffold structure with load capacities suitable for the regeneration of an acetabular bone defect.
In severe cases of total knee arthroplasty, where off-the-shelf implants are not suitable or available anymore (i.e., in cases with extended bone defects or periprosthetic fractures), custom-made knee implants represent one of the few remaining treatment options. Design verification and validation of such custom-made implants is very challenging. The aim of this study is to support surgeons and engineers in their decision on whether a developed design is suitable for the specific case. A novel method for the pre-clinical testing of custom-made knee implants is suggested, which relies on the biomechanical test and finite element analysis (FEA) of a comparable reference implant. The method comprises six steps: (1) identification of the main potential failure mechanism and its corresponding FEA quantity of interest, (2) reproduction of the biomechanical test of the reference implant via FEA, (3) identification of the maximum value of the corresponding FEA quantity of interest at the required load level, (4) definition of this value as the acceptance criterion for the FEA of the custom-made implant, (5) reproduction of the biomechanical test with the custom-made implant via FEA, (6) conclusion, whether the acceptance criterion is fulfilled or not. Two exemplary cases of custom-made knee implants were evaluated with this method. The FEA acceptance criterion derived from the reference implants was fulfilled in both custom-made implants. Subsequent biomechanical tests verified the FEA results. The suggested method allows a quantitative evaluation of the biomechanical properties of a custom-made knee implant without performing a biomechanical test with it. This represents an important contribution in the pre-clinical testing of custom-made implants in order to achieve a sustainable treatment of complex revision total knee arthroplasty patients in a timely manner.
Hip implant failure is mainly due to aseptic loosening of the cotyle and is typically accompanied by defects in the acetabular region. Revision surgery aims to repair such defects before implantation by means of reconstruction materials, whose morselized bone graft represents the gold standard. Due to the limited availability of bone tissue, synthetic substitutes are also used. The aim of this study was to evaluate if a synthetic fully resorbable tri-calcium phosphate-based substitute can provide adequate mechanical stability when employed to restore severe, contained defects, in comparison with morselized bone graft. Five cadaveric pelvises were adopted, one side was reconstructed with morselized bone graft and the other with the synthetic substitute, consisting of dense calcium phosphate granules within a collagen matrix. During the biomechanical test, cyclic load packages of increasing magnitude were applied to each specimen until failure. Bone/implant motions were measured through Digital Image Correlation and were expressed in terms of permanent and inducible translations and rotations. The reconstruction types exhibited a similar behavior, consisting of an initial settling trend followed by failure as bone fracture (i.e., no failure of the reconstruction material). When 2.2 Body Weight was applied, the permanent translations were not significantly different between the two reconstructions (p = 0.06–1.0) and were below 1.0 mm. Similarly, the inducible translations did not differ significantly (p = 0.06–1.0) and were below 0.160 mm. Rotations presented the same order of magnitude but were qualitatively different. Overall, the synthetic substitute provided adequate mechanical stability in comparison with morselized bone graft, thus representing a reliable alternative to treat severe, contained acetabular defects.