The current use of a spherical prosthetic humeral head in total shoulder arthroplasty results in an imprecise restoration of the native geometry and improper placement of the center of rotation, maintained in a constant position, in comparison to the native head and regardless of glenoid component conformity. A radially-mismatched spherical head to allow gleno-humeral translation is a trade-off that decreases the contact area on the glenoid component, which may cause glenoid component wear. This finding suggests that the use of a non-spherical head with a more conforming glenoid component may reduce the risk of glenoid component wear by allowing gleno-humeral translation while increasing the contact area. A non-spherical prosthetic head more accurately replicates the head shape, rotational range of motion and gleno-humeral joint kinematics than a spherical prosthetic head, compared with the native humeral head. The combination of inversion of the bearing materials with the non-spherical configuration of the humeral head may thus decrease polyethylene wear. Aim of the present study is to evaluate in vitro wear behaviour of an all-polyethylene elliptical humeral head component against a metallic glenoid component in an anatomic configuration. The prosthetic components tested are from the Mirai® Modular Shoulder System by Permedica S.p.A.. The prosthetic bearing components were tested in their anatomic configuration: the humeral head rubbing against the glenoid inlay, assembled over the glenoid base-plate. The glenoid insert is made of Ti6Al4V alloy coated with TiNbN. The glenoid insert, as the glenoid base-plate have the same shape which reproduce the native shape of the glenoid. Moreover, the glenoid insert has a concave articular surface described by two different radii on orthogonal planes. The vitamin E-blended UHMWPE humeral head is not spherical but elliptic-shaped with an articular surface described by two different profiles in sagittal and coronal plane. The component sizes combination tested have the greatest radial mismatches allowed between humeral head and glenoid insert. The test was performed up to 2.5 million of cycles applying a constant axial load of 756 N.Background
Material and methods
The osteointegration of a new three-dimensional reticular titanium material, Trabecular Titanium™, was assessed using a bilateral cancellous (distal femur, proximal tibia) and cortical (tibia diaphysis) bone drill hole model in 18 sheep. TT is a novel Ti6Al4V material characterized by a high open porosity and composed of multi-planar regular hexagonal cells. Two 5.0 mm diameter, 12 mm long cylinders (TT1 & TT2) of two different porosities (TT1:650 μm, TT2:1250 μm) were tested and compared to two solid predicate 5.0 mm diameter, 12 mm long Ti cylinders (PT1 & PT2) coated with porous Ti (PT1: vacuum-plasma spray coating; PT2: inert-gas shielding arc spray coating). Each implant type was surgically implanted at 4 separate locations in each sheep (16 implants per sheep). Three timepoints of 4, 16 and 52 weeks (n=6 sheep per timepoint) were used. Bone-implant interface was analyzed ex vivo by the determination of: 1) the shear strength (SS) measured during a push out test, 2) the percentage of bone in-growth (%B) using histomorphometry, 3) the bone apposition rate using fluorochrome labelling analysis and 4) the bone-implant contact using backscattered scanning electron microscopy (SEM). An ANOVA with a Bonferroni Post hoc test were used to detect differences between tested and predicate implants. P values 0.05 were considered significant. At 4 weeks, 5 out of the 6 TT1 could be pushed out of the cortical bone (COB) samples. The remaining TT1 collapsed during testing. All TT1 could be pushed of the cancellous bone (CAB) samples. Four out of the 6 TT2 could be pushed out of CAB and of the COB samples. At 16 and 52 weeks, only one TT1 and one TT2 could be pushed out of the bone samples, the remaining implants collapsed during testing. All the PTs were successfully pushed out at all timepoints. The mean %B of PT1 and PT2 did not significantly increase over time. For both materials, the mean %B ranged between 1.7% and 4.4% at 4 weeks and between 5.7% and 6.5% at 52 weeks. The mean %B of TT1 significantly increased over time in both COB (10.2% at 4 weeks, 46.2% at 16 weeks, 50.5% at 52 weeks) and CAB (5.8%, 23.9%, 24.3%). Similarly, the mean %B of TT2 significantly increased over time in both COB (7.8%, 48.6%, 65%) and CAB (4.5%, 24.1%, 38.6%). Bone apposition rates for the TT implants remained superior to 2 μm/day for the entire duration of the study. SEM showed an intimate bone-implant contact for all implant types at all timepoints. At 16 and 52 weeks, histomorphometry revealed an extensive osteointegration of the TT specimens. Bone-implant interface strength was so high for the TT implants that they could not be pushed out of the bone samples. The results of this study would indicate that the TT implants provide a good scaffold for bone in-growth.
Trabecular Titanium™ is an innovative material characterised by an high open porosity and composed by multi-planar regular hexagonal cells. It is not a traditional coating and its tri-dimensional structure has been studied to optimise osteointegration. Furthermore, it has excellent mechanical properties, as a very high tensile and fatigue resistance and an elastic module very similar to the that of the trabecular bone. The aim of this study is to evaluate the osteointegration and bone remodelling measuring the longitudinal pattern of change in BMD around a cementless acetabular cup made from Trabecular Titanium™ (Delta TT cup, Lima Corporate, Italy) in primary total hip arthroplasty (THA). Dual-energy x-ray absorptiometry (DEXA) analysis, radiographic evaluation on standard AP and lateral views and clinical evaluation with Harris Hip Score (HHS) and SF-36 were performed at 1 week, 3, 6, 12 months after surgery.INTRODUCTION
METHODS
